https://www.ema.europa.eu/en/homepageWhat's newen-gbCopyright: (C) European Medicines AgencySun, 30 Jun 2024 04:02:12 +0200Fri, 28 Jun 2024 22:58:00 +0200https://www.ema.europa.eu/en/medicines/veterinary/EPAR/palladiaVeterinary medicines European public assessment report (EPAR): Palladia, toceranib, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/palladiaFri, 28 Jun 2024 22:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zuprevoVeterinary medicines European public assessment report (EPAR): Zuprevo, tildipirosin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zuprevoFri, 28 Jun 2024 22:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/ypozaneVeterinary medicines European public assessment report (EPAR): Ypozane, osaterone acetate, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/ypozaneFri, 28 Jun 2024 22:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zactranVeterinary medicines European public assessment report (EPAR): Zactran, gamithromycin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zactranFri, 28 Jun 2024 20:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/sevofloVeterinary medicines European public assessment report (EPAR): SevoFlo, sevoflurane, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/sevofloFri, 28 Jun 2024 20:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto-plusVeterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner,moxidectin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravecto-plusFri, 28 Jun 2024 19:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/naxcelVeterinary medicines European public assessment report (EPAR): Naxcel, ceftiofur, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/naxcelFri, 28 Jun 2024 19:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/onsiorVeterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/onsiorFri, 28 Jun 2024 19:07:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/aservo-equihalerVeterinary medicines European public assessment report (EPAR): Aservo EquiHaler, ciclesonide, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/aservo-equihalerFri, 28 Jun 2024 18:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/strongholdVeterinary medicines European public assessment report (EPAR): Stronghold, selamectin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/strongholdFri, 28 Jun 2024 18:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/cereniaVeterinary medicines European public assessment report (EPAR): Cerenia, maropitant, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/cereniaFri, 28 Jun 2024 17:42:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/annex-interim-measures-regarding-notification-pharmacovigilance-alerts-marketing-author-en.pdfAnnex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact pointshttps://www.ema.europa.eu/system/files/documents/other/annex-interim-measures-regarding-notification-pharmacovigilance-alerts-marketing-author-en.pdfFri, 28 Jun 2024 16:44:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-notifications-results-en.xlsxClinical Trial Information System (CTIS) structured data form - Notifications and resultshttps://www.ema.europa.eu/system/files/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-notifications-results-en.xlsxFri, 28 Jun 2024 16:41:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xeravaHuman medicines European public assessment report (EPAR): Xerava, eravacycline, Date of authorisation: 20/09/2018, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xeravaFri, 28 Jun 2024 16:25:00 +0200What's newhttps://www.ema.europa.eu/en/events/public-webinar-pack-size-submissions-xevmpd-product-management-service-pmsPublic webinar on pack size submissions: from XEVMPD to product management service (PMS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 July 2024, 10:00 (CEST) to 11 July 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/public-webinar-pack-size-submissions-xevmpd-product-management-service-pmsFri, 28 Jun 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/20240711_pack-sizes-submissions-training_en.pdfAgenda - Public webinar on pack size submissions: from XEVMPD to product management service (PMS)https://www.ema.europa.eu/system/files/documents/agenda/20240711_pack-sizes-submissions-training_en.pdfFri, 28 Jun 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/events/product-management-service-pms-application-programming-interface-api-training-sessionProduct Management Service (PMS) Application Programming Interface (API) training session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2024, 14:00 (CEST) to 8 July 2024, 15:30 (CEST)https://www.ema.europa.eu/en/events/product-management-service-pms-application-programming-interface-api-training-sessionFri, 28 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zabdenoHuman medicines European public assessment report (EPAR): Zabdeno, ebola vaccine (Ad26.ZEBOV-GP [recombinant]), Date of authorisation: 01/07/2020, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zabdenoFri, 28 Jun 2024 15:51:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificatesPlasma master file certificateshttps://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificatesFri, 28 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/events/quarterly-system-demo-q2-2024Quarterly System Demo – Q2 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2024, 09:00 (CEST) to 26 June 2024, 13:30 (CEST)https://www.ema.europa.eu/en/events/quarterly-system-demo-q2-2024Fri, 28 Jun 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-recombinant-coagulation-factor-ix-products-scientific-guidelineCore summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guidelinehttps://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-recombinant-coagulation-factor-ix-products-scientific-guidelineFri, 28 Jun 2024 14:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vizamylHuman medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Date of authorisation: 22/08/2014, Revision: 18, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vizamylFri, 28 Jun 2024 14:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mepseviiHuman medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Date of authorisation: 23/08/2018, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mepseviiFri, 28 Jun 2024 14:43:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/cresembaSummary of opinion: Cresemba, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/cresembaFri, 28 Jun 2024 14:41:00 +0200What's newhttps://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-ix-products-scientific-guidelineClinical investigation of recombinant and human plasma-derived factor IX products - Scientific guidelinehttps://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-ix-products-scientific-guidelineFri, 28 Jun 2024 14:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/lorazepam-macure-4-mg-ml-solution-injectionReferral: Lorazepam Macure 4 mg/ml, solution for injection, lorazepam Article 13 referrals CHMP opinion, 27/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/lorazepam-macure-4-mg-ml-solution-injectionFri, 28 Jun 2024 14:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nplateHuman medicines European public assessment report (EPAR): Nplate, romiplostim, Date of authorisation: 04/02/2009, Revision: 28, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nplateFri, 28 Jun 2024 14:29:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/spinrazaHuman medicines European public assessment report (EPAR): Spinraza, nusinersen, Date of authorisation: 30/05/2017, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/spinrazaFri, 28 Jun 2024 14:28:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/mandate-scientific-advice-working-party-ema-chmp-sawp-69686-04-rev-18-en.pdfMandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)https://www.ema.europa.eu/system/files/documents/other/mandate-scientific-advice-working-party-ema-chmp-sawp-69686-04-rev-18-en.pdfFri, 28 Jun 2024 14:18:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ctis-sponsor-handbook-2024_v4-en.pdfClinical Trial Information System (CTIS) - Sponsor handbookhttps://www.ema.europa.eu/system/files/documents/other/ctis-sponsor-handbook-2024_v4-en.pdfFri, 28 Jun 2024 14:13:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/paediatric-investigation-plan-pip-key-elements-guidance_en.pdfPaediatric investigation plan (PIP) - Key elements guidancehttps://www.ema.europa.eu/system/files/documents/template-form/paediatric-investigation-plan-pip-key-elements-guidance_en.pdfFri, 28 Jun 2024 13:59:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-28-june-2024-en.pdfCTIS newsflash - 28 June 2024https://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-28-june-2024-en.pdfFri, 28 Jun 2024 13:56:58 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/neulastaHuman medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Date of authorisation: 22/08/2002, Revision: 40, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/neulastaFri, 28 Jun 2024 13:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/repathaHuman medicines European public assessment report (EPAR): Repatha, evolocumab, Date of authorisation: 17/07/2015, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/repathaFri, 28 Jun 2024 13:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aranespHuman medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Date of authorisation: 08/06/2001, Revision: 46, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aranespFri, 28 Jun 2024 13:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliHuman medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aspaveliFri, 28 Jun 2024 13:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/talveyHuman medicines European public assessment report (EPAR): Talvey, talquetamab, Date of authorisation: 21/08/2023, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/talveyFri, 28 Jun 2024 13:16:00 +0200What's newhttps://www.ema.europa.eu/en/conduct-efficacy-studies-intramammary-products-use-cattle-scientific-guidelineConduct of efficacy studies for intramammary products for use in cattle - Scientific guidelinehttps://www.ema.europa.eu/en/conduct-efficacy-studies-intramammary-products-use-cattle-scientific-guidelineFri, 28 Jun 2024 13:00:00 +0200What's newhttps://www.ema.europa.eu/en/demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-scientific-guidelineDemonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guidelinehttps://www.ema.europa.eu/en/demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-scientific-guidelineFri, 28 Jun 2024 13:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/gl-conduct-efficacy-studies-intramammary-products-use-cattle_en.pdfDraft guideline on the conduct of efficacy studies for intramammary products for use in cattlehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/gl-conduct-efficacy-studies-intramammary-products-use-cattle_en.pdfFri, 28 Jun 2024 13:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aquiptaHuman medicines European public assessment report (EPAR): Aquipta, atogepant, Date of authorisation: 11/08/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aquiptaFri, 28 Jun 2024 12:40:00 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024Fri, 28 Jun 2024 12:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/vabysmoSummary of opinion: Vabysmo, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/vabysmoFri, 28 Jun 2024 12:00:45 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/tepkinlySummary of opinion: Tepkinly, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/tepkinlyFri, 28 Jun 2024 12:00:41 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/beyfortusSummary of opinion: Beyfortus, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/beyfortusFri, 28 Jun 2024 12:00:38 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/betmigaSummary of opinion: Betmiga, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/betmigaFri, 28 Jun 2024 12:00:25 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/imcivree-0Summary of opinion: Imcivree, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/imcivree-0Fri, 28 Jun 2024 12:00:03 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/lynparzaSummary of opinion: Lynparza, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/lynparzaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/imfinzi-0Summary of opinion: Imfinzi, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/imfinzi-0Fri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/news/first-nasal-adrenaline-spray-emergency-treatment-against-allergic-reactionsFirst nasal adrenaline spray for emergency treatment against allergic reactionshttps://www.ema.europa.eu/en/news/first-nasal-adrenaline-spray-emergency-treatment-against-allergic-reactionsFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/news/ema-recommends-revoking-conditional-marketing-authorisation-ocalivaEMA recommends revoking conditional marketing authorisation for Ocalivahttps://www.ema.europa.eu/en/news/ema-recommends-revoking-conditional-marketing-authorisation-ocalivaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertensionPositive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertensionhttps://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertensionFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/xalkoriSummary of opinion: Xalkori, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/xalkoriFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/infanrix-hexaSummary of opinion: Infanrix Hexa, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/infanrix-hexaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-tevaHuman medicines European public assessment report (EPAR): Dabigatran etexilate Teva , dabigatran etexilate, Status: Withdrawn application (after opinion)https://www.ema.europa.eu/en/medicines/human/EPAR/dabigatran-etexilate-tevaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/variation/pegasysSummary of opinion: Pegasys, 27/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/human/variation/pegasysFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/winrevairHuman medicines European public assessment report (EPAR): Winrevair, Sotatercept, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/winrevairFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/piaskyHuman medicines European public assessment report (EPAR): Piasky, Crovalimab, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/piaskyFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ordsponoHuman medicines European public assessment report (EPAR): Ordspono, Odronextamab, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/ordsponoFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accordHuman medicines European public assessment report (EPAR): Nilotinib Accord, nilotinib, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accordFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mresviaHuman medicines European public assessment report (EPAR): Mresvia, Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/mresviaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/eurneffyHuman medicines European public assessment report (EPAR): Eurneffy, epinephrine, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/eurneffyFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatrisHuman medicines European public assessment report (EPAR): Enzalutamide Viatris, enzalutamide, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatrisFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/balversaHuman medicines European public assessment report (EPAR): Balversa, Erdafitinib, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/balversaFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2649Orphan designation: Odronextamab Treatment of follicular lymphoma, 18/07/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2649Fri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2656Orphan designation: Odronextamab Treatment of diffuse large B-cell lymphoma, 18/07/2022 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2656Fri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2369Orphan designation: sotatercept Treatment of pulmonary arterial hypertension, 09/12/2020 Positivehttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2369Fri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/hydroxyprogesterone-caproate-containing-medicinal-productsReferral: Hydroxyprogesterone caproate-containing medicinal products, hydroxyprogesterone caproate, associated names: Lentogest,Progesterone Retard Pharlon,Proluton Depot Article 31 referrals CMDh position, 28/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/hydroxyprogesterone-caproate-containing-medicinal-productsFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-61-superseded_en.docTransfer of MA templates Attachment 6.1 (Superseded)https://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-61-superseded_en.docFri, 28 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/q-classification-veterinary-medicinal-products_en.pdfQuestions and answers on classification of veterinary medicinal productshttps://www.ema.europa.eu/system/files/documents/other/q-classification-veterinary-medicinal-products_en.pdfFri, 28 Jun 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-21-23-may-2024Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 May 2024, European Medicines Agency, Amsterdam, the Netherlands, from 21 May 2024 to 23 May 2024https://www.ema.europa.eu/en/events/committee-medicinal-products-veterinary-use-cvmp-21-23-may-2024Fri, 28 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/cvmp-may-2024-minutes_en.pdfMinutes of the CVMP meeting 21-22 May 2024https://www.ema.europa.eu/system/files/documents/minutes/cvmp-may-2024-minutes_en.pdfFri, 28 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-4-superseded_en.docTransfer of MA templates Attachment 4 (Superseded)https://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-4-superseded_en.docFri, 28 Jun 2024 10:57:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-herbal-medicinal-products-hmpc-27-29-may-2024Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024, European Medicines Agency, Amsterdam, the Netherlands, from 27 May 2024 to 29 May 2024https://www.ema.europa.eu/en/events/committee-herbal-medicinal-products-hmpc-27-29-may-2024Fri, 28 Jun 2024 10:36:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/report/hmpc-public-meeting-report-27-29-may-2024_en.pdfHMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-29 May 2024https://www.ema.europa.eu/system/files/documents/report/hmpc-public-meeting-report-27-29-may-2024_en.pdfFri, 28 Jun 2024 10:36:00 +0200What's newhttps://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarnahttps://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0Fri, 28 Jun 2024 10:32:22 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-64-superseded_en.docTransfer of MA templates Attachment 6.4 (Superseded)https://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-64-superseded_en.docFri, 28 Jun 2024 10:29:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-611-no-longer-valid_en.docTransfer of MA templates Attachment 6.1.1 (No longer valid)https://www.ema.europa.eu/system/files/documents/template-form/transfer-ma-templates-attachment-611-no-longer-valid_en.docFri, 28 Jun 2024 09:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xydalbaHuman medicines European public assessment report (EPAR): Xydalba, dalbavancin, Date of authorisation: 19/02/2015, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xydalbaThu, 27 Jun 2024 18:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-chmp-agenda-annex-agenda-24-27-june-2024-publication_en_0.pdfAgenda of the CHMP meeting 24-27 June 2024https://www.ema.europa.eu/system/files/documents/agenda/draft-chmp-agenda-annex-agenda-24-27-june-2024-publication_en_0.pdfThu, 27 Jun 2024 17:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/surgiflo-haemostatic-matrix-kit-ferrosan-procedural-steps-scientific-information-after-initial-consultation_en.pdfSurgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultationhttps://www.ema.europa.eu/system/files/documents/other/surgiflo-haemostatic-matrix-kit-ferrosan-procedural-steps-scientific-information-after-initial-consultation_en.pdfThu, 27 Jun 2024 16:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/adcetrisHuman medicines European public assessment report (EPAR): Adcetris, brentuximab vedotin, Date of authorisation: 25/10/2012, Revision: 35, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/adcetrisThu, 27 Jun 2024 15:46:06 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xtandiHuman medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xtandiThu, 27 Jun 2024 15:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rydaptHuman medicines European public assessment report (EPAR): Rydapt, midostaurin, Date of authorisation: 18/09/2017, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rydaptThu, 27 Jun 2024 15:43:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvoHuman medicines European public assessment report (EPAR): Uzpruvo, ustekinumab, Date of authorisation: 05/01/2024, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvoThu, 27 Jun 2024 15:41:00 +0200What's newhttps://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-sponsors-october-2024Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors - October 2024, Online, from 10 October 2024 to 11 October 2024https://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-sponsors-october-2024Thu, 27 Jun 2024 15:40:00 +0200What's newhttps://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-november-2024eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2024, Online, from 18 November 2024 to 20 November 2024https://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-november-2024Thu, 27 Jun 2024 15:38:30 +0200What's newhttps://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-october-2024eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October 2024, Online, from 22 October 2024 to 24 October 2024https://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-october-2024Thu, 27 Jun 2024 15:37:30 +0200What's newhttps://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-september-2024eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2024, Online, from 10 September 2024 to 12 September 2024https://www.ema.europa.eu/en/events/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-september-2024Thu, 27 Jun 2024 15:35:30 +0200What's newhttps://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-september-2024Clinical Trials Information System (CTIS): Walk-in clinic - September 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 September 2024, 16:00 (CEST) to 18 September 2024, 17:00 (CEST)https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-september-2024Thu, 27 Jun 2024 15:07:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-ad-hoc-executive-steering-group-shortages-safety-medicinal-products-en.pdfAgenda - Ad-hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), 1 July 2024https://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-ad-hoc-executive-steering-group-shortages-safety-medicinal-products-en.pdfThu, 27 Jun 2024 14:56:38 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-accordpharmaHuman medicines European public assessment report (EPAR): Cinacalcet Accordpharma, cinacalcet, Date of authorisation: 03/04/2020, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cinacalcet-accordpharmaThu, 27 Jun 2024 14:56:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/business-hours-holidaysBusiness hours and holidayshttps://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/business-hours-holidaysThu, 27 Jun 2024 14:28:28 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/inhixaHuman medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 27, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/inhixaThu, 27 Jun 2024 14:23:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/qa-stakeholders-implications-regulation-eu-20231182-centrally-authorised-medic_en.pdfQuestions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human usehttps://www.ema.europa.eu/system/files/documents/other/qa-stakeholders-implications-regulation-eu-20231182-centrally-authorised-medic_en.pdfThu, 27 Jun 2024 13:53:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vekluryHuman medicines European public assessment report (EPAR): Veklury, remdesivir, Date of authorisation: 03/07/2020, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vekluryThu, 27 Jun 2024 12:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zeposiaHuman medicines European public assessment report (EPAR): Zeposia, ozanimod, Date of authorisation: 20/05/2020, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zeposiaThu, 27 Jun 2024 12:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/eyleaHuman medicines European public assessment report (EPAR): Eylea, aflibercept, Date of authorisation: 21/11/2012, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/eyleaThu, 27 Jun 2024 11:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/orenciaHuman medicines European public assessment report (EPAR): Orencia, abatacept, Date of authorisation: 21/05/2007, Revision: 40, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/orenciaThu, 27 Jun 2024 11:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/livmarliHuman medicines European public assessment report (EPAR): Livmarli, Maralixibat chloride, Date of authorisation: 09/12/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/livmarliThu, 27 Jun 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-595Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E Treatment of peripheral T-cell lymphoma, 21/08/2019 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-595Wed, 26 Jun 2024 17:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-596Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) Treatment of Hodgkin's lymphoma, 15/01/2009 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-596Wed, 26 Jun 2024 17:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-11-939Orphan designation: Brentuximab vedotin Treatment of cutaneous T-cell lymphoma, 11/01/2012 Withdrawnhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-11-939Wed, 26 Jun 2024 17:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/annex-xv-list-topiramate-containing-medicinal-products-european-union_en.pdfAnnex XV - List of topiramate containing medicinal products in the European Unionhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/annex-xv-list-topiramate-containing-medicinal-products-european-union_en.pdfWed, 26 Jun 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/annex-xv-list-topiramate-containing-medicinal-products-european-union_en.xlsxAnnex XV - List of topiramate containing medicinal products in the European Unionhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/annex-xv-list-topiramate-containing-medicinal-products-european-union_en.xlsxWed, 26 Jun 2024 16:11:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_en_0.pdfList of medicinal products under additional monitoringhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_en_0.pdfWed, 26 Jun 2024 16:10:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_en_0.xlsxList of medicinal products under additional monitoringhttps://www.ema.europa.eu/system/files/documents/additional-monitoring/list-medicinal-products-under-additional-monitoring_en_0.xlsxWed, 26 Jun 2024 16:09:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/roactemraHuman medicines European public assessment report (EPAR): RoActemra, tocilizumab, Date of authorisation: 16/01/2009, Revision: 44, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/roactemraWed, 26 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/recommendations-mssg-shortage-glp-1-receptor-agonists_en.pdfMSSG recommendations on shortage of Glucagon-Like Peptide-1 (GLP-1) receptor agonistshttps://www.ema.europa.eu/system/files/documents/other/recommendations-mssg-shortage-glp-1-receptor-agonists_en.pdfWed, 26 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonistsEU actions to tackle shortages of GLP-1 receptor agonistshttps://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonistsWed, 26 Jun 2024 15:29:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta-0Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Date of authorisation: 06/11/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta-0Wed, 26 Jun 2024 15:20:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crisesAvailability of medicines before and during criseshttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crisesWed, 26 Jun 2024 15:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/valdoxanHuman medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Date of authorisation: 19/02/2009, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/valdoxanWed, 26 Jun 2024 15:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/artesunate-amivasHuman medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Date of authorisation: 22/11/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/artesunate-amivasWed, 26 Jun 2024 15:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/twelfth-meeting-industry-stakeholder-platform-research-development-supportTwelfth meeting of the industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, 4 July 2024https://www.ema.europa.eu/en/events/twelfth-meeting-industry-stakeholder-platform-research-development-supportWed, 26 Jun 2024 14:58:50 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/yervoyHuman medicines European public assessment report (EPAR): Yervoy, ipilimumab, Date of authorisation: 13/07/2011, Revision: 55, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/yervoyWed, 26 Jun 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-zentiva-previously-leflunomide-winthropHuman medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Date of authorisation: 08/01/2010, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-zentiva-previously-leflunomide-winthropWed, 26 Jun 2024 14:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-0Human medicines European public assessment report (EPAR): Fluenz, influenza vaccine (live attenuated, nasal), Date of authorisation: 03/06/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-0Wed, 26 Jun 2024 14:45:00 +0200What's newhttps://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-adviceScientific advice for veterinary medicineshttps://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-adviceWed, 26 Jun 2024 13:55:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema-fda-veterinary-parallel-scientific-advice-timetable_en_0.pdfEMA and FDA-CVM parallel scientific advice timetablehttps://www.ema.europa.eu/system/files/documents/other/ema-fda-veterinary-parallel-scientific-advice-timetable_en_0.pdfWed, 26 Jun 2024 13:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ebvalloHuman medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ebvalloWed, 26 Jun 2024 13:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/hyqviaHuman medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Date of authorisation: 16/05/2013, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/hyqviaWed, 26 Jun 2024 13:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/supemtekHuman medicines European public assessment report (EPAR): Supemtek, Quadrivalent influenza vaccine (recombinant, prepared in cell culture), Date of authorisation: 16/11/2020, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/supemtekWed, 26 Jun 2024 13:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/invanzHuman medicines European public assessment report (EPAR): Invanz, ertapenem, Date of authorisation: 18/04/2002, Revision: 27, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/invanzWed, 26 Jun 2024 13:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/agamreeHuman medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/agamreeWed, 26 Jun 2024 12:11:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/shortage/saxenda-supply-shortage-rev2_en.pdfSaxenda (liraglutide) supply shortagehttps://www.ema.europa.eu/system/files/documents/shortage/saxenda-supply-shortage-rev2_en.pdfWed, 26 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/shortage/trulicity-supply-shortage-rev2_en.pdfTrulicity (dulaglutide) supply shortagehttps://www.ema.europa.eu/system/files/documents/shortage/trulicity-supply-shortage-rev2_en.pdfWed, 26 Jun 2024 11:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lysodrenHuman medicines European public assessment report (EPAR): Lysodren, mitotane, Date of authorisation: 28/04/2004, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lysodrenWed, 26 Jun 2024 11:42:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/about-website/website-outages-upgradesWebsite outages and upgradeshttps://www.ema.europa.eu/en/about-us/about-website/website-outages-upgradesWed, 26 Jun 2024 09:34:13 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/evvet3-evweb-production-release-notes-en_0.pdfEVVet3 EVWeb Production – Release noteshttps://www.ema.europa.eu/system/files/documents/other/evvet3-evweb-production-release-notes-en_0.pdfTue, 25 Jun 2024 17:35:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-hemoglobinopathiesEMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2024, 14:00 (CEST) to 1 July 2024, 18:00 (CEST)https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-hemoglobinopathiesTue, 25 Jun 2024 17:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/exzoltVeterinary medicines European public assessment report (EPAR): Exzolt, fluralaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/exzoltTue, 25 Jun 2024 17:22:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zolvixVeterinary medicines European public assessment report (EPAR): Zolvix, monepantel, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/zolvixTue, 25 Jun 2024 17:12:00 +0200What's newhttps://www.ema.europa.eu/en/events/multistakeholder-workshop-shortages-glucagon-peptide-1-glp-1-receptor-agonistsMultistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 1 July 2024, 12:30 (CEST) to 1 July 2024, 18:30 (CEST)https://www.ema.europa.eu/en/events/multistakeholder-workshop-shortages-glucagon-peptide-1-glp-1-receptor-agonistsTue, 25 Jun 2024 17:02:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-multistakeholder-workshop-shortages-glp-1-ras-1-july-2024-en_0.pdfAgenda - Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonistshttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-multistakeholder-workshop-shortages-glp-1-ras-1-july-2024-en_0.pdfTue, 25 Jun 2024 17:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zercepacHuman medicines European public assessment report (EPAR): Zercepac, trastuzumab, Date of authorisation: 27/07/2020, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zercepacTue, 25 Jun 2024 17:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/trocoxilVeterinary medicines European public assessment report (EPAR): Trocoxil, mavacoxib, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/trocoxilTue, 25 Jun 2024 16:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/neoclaritynHuman medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Date of authorisation: 15/01/2001, Revision: 47, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/neoclaritynTue, 25 Jun 2024 16:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimzelxHuman medicines European public assessment report (EPAR): Bimzelx, bimekizumab, Date of authorisation: 20/08/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimzelxTue, 25 Jun 2024 16:51:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/evictoVeterinary medicines European public assessment report (EPAR): Evicto, selamectin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/evictoTue, 25 Jun 2024 16:46:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/pdco-agenda-25-28-june-2024-en_0.pdfAgenda - PDCO agenda of the 25-28 June 2024 meetinghttps://www.ema.europa.eu/system/files/documents/agenda/pdco-agenda-25-28-june-2024-en_0.pdfTue, 25 Jun 2024 16:45:19 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/semintraVeterinary medicines European public assessment report (EPAR): Semintra, telmisartan, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/semintraTue, 25 Jun 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/apoquelVeterinary medicines European public assessment report (EPAR): Apoquel, oclacitinib maleate, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/apoquelTue, 25 Jun 2024 16:01:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/nilotinib-psbgl-part-b-en.pdfNilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidancehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/nilotinib-psbgl-part-b-en.pdfTue, 25 Jun 2024 15:05:36 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/methylphenidate-psbgl-part-b-en.pdfMethylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidancehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/methylphenidate-psbgl-part-b-en.pdfTue, 25 Jun 2024 15:03:13 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/azomyrHuman medicines European public assessment report (EPAR): Azomyr, desloratadine, Date of authorisation: 15/01/2001, Revision: 53, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/azomyrTue, 25 Jun 2024 13:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aeriusHuman medicines European public assessment report (EPAR): Aerius, desloratadine, Date of authorisation: 15/01/2001, Revision: 51, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aeriusTue, 25 Jun 2024 13:53:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/annual-reports-work-programmesAnnual reports and work programmeshttps://www.ema.europa.eu/en/about-us/annual-reports-work-programmesTue, 25 Jun 2024 12:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-accordHuman medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Date of authorisation: 30/06/2013, Revision: 21, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-accordTue, 25 Jun 2024 12:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/finleeHuman medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/finleeTue, 25 Jun 2024 11:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/spexotrasHuman medicines European public assessment report (EPAR): Spexotras, trametinib, Date of authorisation: 05/01/2024, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/spexotrasTue, 25 Jun 2024 11:50:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/management-board-meeting-dates-2025-2026_en.pdfManagement Board meeting dates 2025-2026https://www.ema.europa.eu/system/files/documents/other/management-board-meeting-dates-2025-2026_en.pdfTue, 25 Jun 2024 11:17:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/outcome-written-procedures-finalised-during-period-12-march-03-june-2024_en.pdfOutcome of written procedures finalised during the period from 12 March to 03 June 2024https://www.ema.europa.eu/system/files/documents/other/outcome-written-procedures-finalised-during-period-12-march-03-june-2024_en.pdfTue, 25 Jun 2024 11:12:00 +0200What's newhttps://www.ema.europa.eu/en/events/webinar-industry-contract-research-organisations-cros-revised-environmental-risk-assessment-era-guideline-human-medicinal-productsWebinar for industry and contract research organisations (CROs) on revised Environmental Risk Assessment (ERA) guideline for human medicinal products, Online, European Medicines Agency, Amsterdam, the Netherlands, 26 June 2024https://www.ema.europa.eu/en/events/webinar-industry-contract-research-organisations-cros-revised-environmental-risk-assessment-era-guideline-human-medicinal-productsTue, 25 Jun 2024 11:10:23 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/opinions-letters-support-qualification-novel-methodologies-medicine-developmentOpinions and letters of support on the qualification of novel methodologies for medicine developmenthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/opinions-letters-support-qualification-novel-methodologies-medicine-developmentTue, 25 Jun 2024 09:44:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/comments/overview-comments-received-draft-qualification-opinion-centiloid-measure-amyloid-pe-en.pdfOverview of comments received on draft qualification opinion for Centiloid measure of Amyloid PET to quantify brain amyloid depositionhttps://www.ema.europa.eu/system/files/documents/comments/overview-comments-received-draft-qualification-opinion-centiloid-measure-amyloid-pe-en.pdfTue, 25 Jun 2024 09:43:31 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/qualification-opinion-centiloid-measure-amyloid-pet-quantify-brain-amyloid-deposition-en.pdfQualification opinion for Centiloid measure of Amyloid PET to quantify brain amyloid depositionhttps://www.ema.europa.eu/system/files/documents/other/qualification-opinion-centiloid-measure-amyloid-pet-quantify-brain-amyloid-deposition-en.pdfTue, 25 Jun 2024 09:42:24 +0200What's newhttps://www.ema.europa.eu/system/files/documents/scientific-guideline/budesonide-psbgl-_pr_tablets-part-b_2-en.pdfBudesonide, prolonged release tablets, 9 mg product-specific bioequivalence guidancehttps://www.ema.europa.eu/system/files/documents/scientific-guideline/budesonide-psbgl-_pr_tablets-part-b_2-en.pdfTue, 25 Jun 2024 08:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ocrevusHuman medicines European public assessment report (EPAR): Ocrevus, ocrelizumab, Date of authorisation: 08/01/2018, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ocrevusMon, 24 Jun 2024 16:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jylamvoHuman medicines European public assessment report (EPAR): Jylamvo, methotrexate, Date of authorisation: 29/03/2017, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/jylamvoMon, 24 Jun 2024 15:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xaluprine-previously-mercaptopurine-nova-laboratoriesHuman medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), mercaptopurine, Date of authorisation: 09/03/2012, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xaluprine-previously-mercaptopurine-nova-laboratoriesMon, 24 Jun 2024 15:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jemperliHuman medicines European public assessment report (EPAR): Jemperli, dostarlimab, Date of authorisation: 21/04/2021, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/jemperliMon, 24 Jun 2024 15:51:00 +0200What's newhttps://www.ema.europa.eu/en/events/ninth-industry-standing-group-isg-meetingNinth Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 June 2024, 09:00 (CEST) to 28 June 2024, 13:25 (CEST)https://www.ema.europa.eu/en/events/ninth-industry-standing-group-isg-meetingMon, 24 Jun 2024 15:25:54 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abecmaHuman medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Date of authorisation: 18/08/2021, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abecmaMon, 24 Jun 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/constellaHuman medicines European public assessment report (EPAR): Constella, linaclotide, Date of authorisation: 26/11/2012, Revision: 26, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/constellaMon, 24 Jun 2024 15:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/piqrayHuman medicines European public assessment report (EPAR): Piqray, alpelisib, Date of authorisation: 27/07/2020, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/piqrayMon, 24 Jun 2024 15:07:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lutatheraHuman medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Date of authorisation: 26/09/2017, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lutatheraMon, 24 Jun 2024 15:06:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/contractor-mlm-sops-wins-april-2024-en.zipContractor SOP/MLM - WIN/MLMhttps://www.ema.europa.eu/system/files/documents/other/contractor-mlm-sops-wins-april-2024-en.zipMon, 24 Jun 2024 14:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/libtayoHuman medicines European public assessment report (EPAR): Libtayo, cemiplimab, Date of authorisation: 28/06/2019, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/libtayoMon, 24 Jun 2024 13:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/first-ema-animal-health-europe-annual-bilateral-meetingFirst EMA-Animal Health Europe annual bilateral meeting , Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2024, 13:30 (CEST) to 1 July 2024, 15:00 (CEST)https://www.ema.europa.eu/en/events/first-ema-animal-health-europe-annual-bilateral-meetingMon, 24 Jun 2024 12:18:09 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiHuman medicines European public assessment report (EPAR): MenQuadfi, meningococcal group A, C, W-135 and Y conjugate vaccine, Date of authorisation: 18/11/2020, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/menquadfiMon, 24 Jun 2024 12:16:00 +0200What's newhttps://www.ema.europa.eu/en/qrd-guidance-use-approved-pictograms-packaging-veterinary-medicinal-products-authorised-centralised-mutual-recognition-decentralised-procedures-species-pictogramsQRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures - Species pictogramshttps://www.ema.europa.eu/en/qrd-guidance-use-approved-pictograms-packaging-veterinary-medicinal-products-authorised-centralised-mutual-recognition-decentralised-procedures-species-pictogramsFri, 21 Jun 2024 15:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/variation/stronghold-plusSummary of opinion: Stronghold Plus, 19/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/veterinary/variation/stronghold-plusFri, 21 Jun 2024 14:37:22 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/variation/rabitec-0Summary of opinion: Rabitec, 19/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/veterinary/variation/rabitec-0Fri, 21 Jun 2024 14:37:19 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/variation/suvaxyn-prrs-mlv-0Summary of opinion: Suvaxyn PRRS MLV, 19/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/veterinary/variation/suvaxyn-prrs-mlv-0Fri, 21 Jun 2024 14:37:03 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-19-june-2024Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-19-june-2024Fri, 21 Jun 2024 14:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/divence-ibr-marker-liveVeterinary medicines European public assessment report (EPAR): Divence IBR Marker Live, Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live, Status: Opinionhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/divence-ibr-marker-liveFri, 21 Jun 2024 14:31:41 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/variation/daxocoxSummary of opinion: Daxocox, 19/06/2024 Positivehttps://www.ema.europa.eu/en/medicines/veterinary/variation/daxocoxFri, 21 Jun 2024 14:16:50 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/glp-compliance-non-clinical-studies-glp-compliance-annex-cover-letter_en-amendments_en.docxGLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)https://www.ema.europa.eu/system/files/documents/template-form/glp-compliance-non-clinical-studies-glp-compliance-annex-cover-letter_en-amendments_en.docxFri, 21 Jun 2024 13:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/202405-list-centrally-authorised-products-requiring-notifications-safety-update-en.pdfList of centrally authorised products requiring a notification of a change for update of annexeshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/202405-list-centrally-authorised-products-requiring-notifications-safety-update-en.pdfFri, 21 Jun 2024 13:22:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/sileoVeterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/sileoFri, 21 Jun 2024 13:10:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/rules-implementation-council-regulation-ec-no-29795-fees-payable-european_en.pdfRules for the implementation of Council Regulation (EC) No 29795 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 May 2024https://www.ema.europa.eu/system/files/documents/other/rules-implementation-council-regulation-ec-no-29795-fees-payable-european_en.pdfFri, 21 Jun 2024 13:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/2025-sawp-meetings-dates-submission-deadlines_en.pdfDates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requestshttps://www.ema.europa.eu/system/files/documents/other/2025-sawp-meetings-dates-submission-deadlines_en.pdfFri, 21 Jun 2024 12:37:00 +0200What's newhttps://www.ema.europa.eu/en/events/new-fee-regulation-webinar-veterinary-marketing-authorisation-holdersNew Fee Regulation: webinar for veterinary Marketing Authorisation Holders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 June 2024, 10:00 (CEST) to 20 June 2024, 11:00 (CEST)https://www.ema.europa.eu/en/events/new-fee-regulation-webinar-veterinary-marketing-authorisation-holdersFri, 21 Jun 2024 12:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdualagHuman medicines European public assessment report (EPAR): Opdualag, relatlimab / nivolumab, Date of authorisation: 15/09/2022, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdualagFri, 21 Jun 2024 11:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vafseoHuman medicines European public assessment report (EPAR): Vafseo, vadadustat, Date of authorisation: 24/04/2023, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vafseoFri, 21 Jun 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/prialtHuman medicines European public assessment report (EPAR): Prialt, ziconotide, Date of authorisation: 21/02/2005, Revision: 31, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/prialtFri, 21 Jun 2024 11:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/triumeqHuman medicines European public assessment report (EPAR): Triumeq, abacavir sulfate / dolutegravir sodium / lamivudine, Date of authorisation: 31/08/2014, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/triumeqFri, 21 Jun 2024 11:18:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platformEuropean Shortages Monitoring Platformhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platformFri, 21 Jun 2024 11:15:00 +0200What's newhttps://www.ema.europa.eu/en/ich-m12-drug-interaction-studies-scientific-guidelineICH M12 on drug interaction studies - Scientific guidelinehttps://www.ema.europa.eu/en/ich-m12-drug-interaction-studies-scientific-guidelineFri, 21 Jun 2024 09:58:00 +0200What's newhttps://www.ema.europa.eu/en/events/twelfth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicinesTwelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 June 2024, 13:00 (CEST) to 19 June 2024, 18:00 (CEST)https://www.ema.europa.eu/en/events/twelfth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicinesFri, 21 Jun 2024 09:52:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-labelling-package-leaflet-article-613-notificationsChanging the labelling and package leaflet (Article 61(3) notifications)https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-labelling-package-leaflet-article-613-notificationsFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answersTransfer of marketing authorisation: questions and answershttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answersFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidancePre-authorisation guidancehttps://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidanceFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/post-authorisation-guidance-integrated-version_june-2024-clean_en.pdfEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/post-authorisation-guidance-integrated-version_june-2024-clean_en.pdfFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/psg-integrated-version_jun-2024_en.pdfEuropean Medicines Agency pre-authorisation procedural advice for users of the centralised procedurehttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/psg-integrated-version_jun-2024_en.pdfFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/post-authorisation-guidance-integrated-version_june-2024-track-changes_en.pdfEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changeshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/post-authorisation-guidance-integrated-version_june-2024-track-changes_en.pdfFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/psg-integrated-version_jun-2024-track-changes_en.pdfEuropean Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changeshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/psg-integrated-version_jun-2024-track-changes_en.pdfFri, 21 Jun 2024 09:20:00 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-july-2024Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2024, 09:30 (CEST) to 1 July 2024, 11:45 (CEST)https://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-july-2024Thu, 20 Jun 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-june-2024Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - June 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 June 2024, 10:00 (CEST) to 26 June 2024, 12:00 (CEST)https://www.ema.europa.eu/en/events/meeting-executive-steering-group-shortages-safety-medicinal-products-mssg-june-2024Thu, 20 Jun 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/events/multi-stakeholder-workshop-pharmacogenomicsMulti-stakeholder workshop on Pharmacogenomics, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2024, 09:00 (CEST) to 24 September 2024, 17:00 (CEST)https://www.ema.europa.eu/en/events/multi-stakeholder-workshop-pharmacogenomicsThu, 20 Jun 2024 16:23:41 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accordHuman medicines European public assessment report (EPAR): Nintedanib Accord, nintedanib, Date of authorisation: 19/04/2024, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accordThu, 20 Jun 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-accordHuman medicines European public assessment report (EPAR): Deferasirox Accord, deferasirox, Date of authorisation: 09/01/2020, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-accordThu, 20 Jun 2024 15:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/luxturnaHuman medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Date of authorisation: 22/11/2018, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/luxturnaThu, 20 Jun 2024 15:48:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/work-programme/workplan-2023-2025-hmaema-joint-big-data-steering-group_en.pdfWorkplan 2023-2025: HMA-EMA joint Big Data Steering Grouphttps://www.ema.europa.eu/system/files/documents/work-programme/workplan-2023-2025-hmaema-joint-big-data-steering-group_en.pdfThu, 20 Jun 2024 15:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cubicinHuman medicines European public assessment report (EPAR): Cubicin, daptomycin, Date of authorisation: 19/01/2006, Revision: 38, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cubicinThu, 20 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-mylanHuman medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Date of authorisation: 19/06/2015, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-mylanThu, 20 Jun 2024 15:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tafinlarHuman medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Date of authorisation: 26/08/2013, Revision: 32, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tafinlarThu, 20 Jun 2024 14:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/camceviHuman medicines European public assessment report (EPAR): Camcevi, leuprorelin, Date of authorisation: 24/05/2022, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/camceviThu, 20 Jun 2024 14:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nilemdoHuman medicines European public assessment report (EPAR): Nilemdo, bempedoic acid, Date of authorisation: 01/04/2020, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nilemdoThu, 20 Jun 2024 13:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nustendiHuman medicines European public assessment report (EPAR): Nustendi, bempedoic acid,ezetimibe, Date of authorisation: 27/03/2020, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nustendiThu, 20 Jun 2024 13:38:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/guide-information-human-medicines-evaluated-ema-update-6_en.pdfGuide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and whenhttps://www.ema.europa.eu/system/files/documents/other/guide-information-human-medicines-evaluated-ema-update-6_en.pdfThu, 20 Jun 2024 13:37:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-press-briefing-eu-actions-tackle-shortages-glp-1-receptor-agonistsEMA press briefing on EU actions to tackle shortages of GLP-1 receptor agonists, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2024, 15:30 (CEST) to 26 June 2024, 16:15 (CEST)https://www.ema.europa.eu/en/events/ema-press-briefing-eu-actions-tackle-shortages-glp-1-receptor-agonistsThu, 20 Jun 2024 11:56:26 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/patient-registriesPatient registrieshttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/patient-registriesThu, 20 Jun 2024 11:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/brimica-genuairHuman medicines European public assessment report (EPAR): Brimica Genuair, aclidinium,formoterol fumarate dihydrate, Date of authorisation: 19/11/2014, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/brimica-genuairThu, 20 Jun 2024 11:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dynastatHuman medicines European public assessment report (EPAR): Dynastat, parecoxib, Date of authorisation: 22/03/2002, Revision: 37, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dynastatThu, 20 Jun 2024 11:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bretaris-genuairHuman medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, Date of authorisation: 20/07/2012, Revision: 19, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bretaris-genuairThu, 20 Jun 2024 11:27:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/atosiban-sunHuman medicines European public assessment report (EPAR): Atosiban SUN, atosiban, Date of authorisation: 31/07/2013, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/atosiban-sunThu, 20 Jun 2024 09:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-krkaHuman medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine,tenofovir disoproxil, Date of authorisation: 09/12/2016, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-krkaThu, 20 Jun 2024 08:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lydisilkaHuman medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lydisilkaWed, 19 Jun 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/adynoviHuman medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Date of authorisation: 08/01/2018, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/adynoviWed, 19 Jun 2024 16:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/advateHuman medicines European public assessment report (EPAR): Advate, octocog alfa, Date of authorisation: 02/03/2004, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/advateWed, 19 Jun 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/evipleraHuman medicines European public assessment report (EPAR): Eviplera, emtricitabine,rilpivirine,tenofovir disoproxil, Date of authorisation: 27/11/2011, Revision: 26, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/evipleraWed, 19 Jun 2024 16:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sondelbayHuman medicines European public assessment report (EPAR): Sondelbay, teriparatide, Date of authorisation: 24/03/2022, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sondelbayWed, 19 Jun 2024 15:59:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/alecensaHuman medicines European public assessment report (EPAR): Alecensa, alectinib, Date of authorisation: 16/02/2017, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/alecensaWed, 19 Jun 2024 15:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xigduoHuman medicines European public assessment report (EPAR): Xigduo, dapagliflozin,metformin, Date of authorisation: 16/01/2014, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xigduoWed, 19 Jun 2024 15:07:00 +0200What's newhttps://www.ema.europa.eu/en/events/act-eu-consolidated-advice-pilots-information-training-webinar-applicantsACT EU consolidated advice pilots: information and training webinar for Applicants, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 17 July 2024, 15:00 (CEST) to 17 July 2024, 17:00 (CEST)https://www.ema.europa.eu/en/events/act-eu-consolidated-advice-pilots-information-training-webinar-applicantsWed, 19 Jun 2024 15:06:33 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/firazyrHuman medicines European public assessment report (EPAR): Firazyr, icatibant, Date of authorisation: 11/07/2008, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/firazyrWed, 19 Jun 2024 13:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/drovelisHuman medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/drovelisWed, 19 Jun 2024 12:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/neoatriconHuman medicines European public assessment report (EPAR): Neoatricon, Dopamine hydrochloride, Date of authorisation: 27/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/neoatriconWed, 19 Jun 2024 12:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/dhpc/zypadheraZypadherahttps://www.ema.europa.eu/en/medicines/dhpc/zypadheraWed, 19 Jun 2024 11:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/memantine-mylanHuman medicines European public assessment report (EPAR): Memantine Mylan, memantine, Date of authorisation: 21/04/2013, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/memantine-mylanTue, 18 Jun 2024 17:24:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm10_faqs_en_0.pdfFAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10https://www.ema.europa.eu/system/files/documents/other/cttm10_faqs_en_0.pdfTue, 18 Jun 2024 16:32:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm02_guide-ctis-common-features_en.pdfClinical Trials Information System (CTIS) common features - CTIS Training Programme - Module 02https://www.ema.europa.eu/system/files/documents/other/cttm02_guide-ctis-common-features_en.pdfTue, 18 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm10_checklist_per_cta-en.pdfChecklist of required fields per application type - CTIS Training Programme - Module 10https://www.ema.europa.eu/system/files/documents/other/cttm10_checklist_per_cta-en.pdfTue, 18 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm10_sbs-guide_en.pdfStep-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications - CTIS Training Programme - Module 10https://www.ema.europa.eu/system/files/documents/other/cttm10_sbs-guide_en.pdfTue, 18 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/cttm11_step-step-guide_en.pdfStep-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11https://www.ema.europa.eu/system/files/documents/other/cttm11_step-step-guide_en.pdfTue, 18 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/authority-workspace-roles-permissions-summary_en.pdfRoles and permissions matrix summary - Authority workspace - CTIS Training Programme - Module 07https://www.ema.europa.eu/system/files/documents/other/authority-workspace-roles-permissions-summary_en.pdfTue, 18 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003376-pip01-22EMEA-003376-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003376-pip01-22Tue, 18 Jun 2024 15:47:32 +0200What's newhttps://www.ema.europa.eu/en/events/industry-update-webinar-regulatory-procedure-management-product-lifecycle-management-irisIndustry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 June 2024, 10:00 (CEST) to 13 June 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/industry-update-webinar-regulatory-procedure-management-product-lifecycle-management-irisTue, 18 Jun 2024 15:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003374-pip01-22EMEA-003374-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003374-pip01-22Tue, 18 Jun 2024 14:50:06 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003373-pip01-22EMEA-003373-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003373-pip01-22Tue, 18 Jun 2024 14:30:17 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003372-pip01-22EMEA-003372-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003372-pip01-22Tue, 18 Jun 2024 14:04:51 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companiesMedicine shortages and availability issues: guidance for companieshttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companiesTue, 18 Jun 2024 13:59:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/shortage-mitigation-plan-smp-template_en.pdfMedicine shortage mitigation plan - templatehttps://www.ema.europa.eu/system/files/documents/other/shortage-mitigation-plan-smp-template_en.pdfTue, 18 Jun 2024 13:58:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/shortage-prevention-plan-spp-template_en.pdfMedicine shortage prevention plan - templatehttps://www.ema.europa.eu/system/files/documents/other/shortage-prevention-plan-spp-template_en.pdfTue, 18 Jun 2024 13:57:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/report-hmpc-aesgp-hearing-2023-november_en.pdfHearing the Association of the European Self-Medication Industry (AESGP) during the November 2023 Working Party meetinghttps://www.ema.europa.eu/system/files/documents/other/report-hmpc-aesgp-hearing-2023-november_en.pdfTue, 18 Jun 2024 13:52:54 +0200What's newhttps://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-multistakeholder-workshop-patient-registriesJoint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2024 to 13 February 2024https://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-multistakeholder-workshop-patient-registriesTue, 18 Jun 2024 13:36:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/ema_grant_2024_02_ia-qa-public_en_2.pdfQuestions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africahttps://www.ema.europa.eu/system/files/documents/other/ema_grant_2024_02_ia-qa-public_en_2.pdfTue, 18 Jun 2024 12:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/management-board-meeting-21-march-2024Management Board meeting: 21 March 2024, European Medicines Agency, Amsterdam, the Netherlands, 21 March 2024https://www.ema.europa.eu/en/events/management-board-meeting-21-march-2024Tue, 18 Jun 2024 12:03:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/minutes-123rd-meeting-management-board_en.pdfMinutes of the 123rd meeting of the Management Board on 21 March 2024https://www.ema.europa.eu/system/files/documents/minutes/minutes-123rd-meeting-management-board_en.pdfTue, 18 Jun 2024 12:02:06 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/steqeymaHuman medicines European public assessment report (EPAR): Steqeyma, ustekinumab, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/steqeymaTue, 18 Jun 2024 12:00:17 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-joint-pcwp-hcpwp-2-3-july-2024_en.pdfAgenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meetinghttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-joint-pcwp-hcpwp-2-3-july-2024_en.pdfTue, 18 Jun 2024 11:55:26 +0200What's newhttps://www.ema.europa.eu/en/events/paediatric-committee-pdco-23-26-april-2024Paediatric Committee (PDCO): 23-26 April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 April 2024 to 26 April 2024https://www.ema.europa.eu/en/events/paediatric-committee-pdco-23-26-april-2024Tue, 18 Jun 2024 11:32:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/pdco-minutes-23-26-april-2024-publication_en.pdfPDCO minutes of the 23-26 April 2024 meetinghttps://www.ema.europa.eu/system/files/documents/minutes/pdco-minutes-23-26-april-2024-publication_en.pdfTue, 18 Jun 2024 11:30:47 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/prunus-avium-peduncleHerbal medicinal product: Prunus avium peduncleArray,Array, D: Draft under discussionhttps://www.ema.europa.eu/en/medicines/herbal/prunus-avium-peduncleTue, 18 Jun 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-comp-agenda-18-20-june-2024-en.pdfAgenda of the COMP meeting 18-20 June 2024https://www.ema.europa.eu/system/files/documents/agenda/draft-comp-agenda-18-20-june-2024-en.pdfTue, 18 Jun 2024 11:21:58 +0200What's newhttps://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europeFaster access to clinical trial information in Europehttps://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europeTue, 18 Jun 2024 11:12:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportClinical Trials Information System: training and supporthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-training-supportTue, 18 Jun 2024 11:11:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-systemClinical Trials Information Systemhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-systemTue, 18 Jun 2024 11:07:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system/development-clinical-trials-information-systemDevelopment of the Clinical Trials Information Systemhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system/development-clinical-trials-information-systemTue, 18 Jun 2024 11:04:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/superseded_appendix-transparency-rules-functional-specifications-eu-clinical_en_0.pdfAppendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be auditedhttps://www.ema.europa.eu/system/files/documents/other/superseded_appendix-transparency-rules-functional-specifications-eu-clinical_en_0.pdfTue, 18 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/ctis-structured-data-form-additional-msc-sm-non-sm_en_0.xlsxClinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationhttps://www.ema.europa.eu/system/files/documents/template-form/ctis-structured-data-form-additional-msc-sm-non-sm_en_0.xlsxTue, 18 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-request-information-rfi_en.xlsxClinical Trial Information System (CTIS) structured data form - Request for information (RFI)https://www.ema.europa.eu/system/files/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-request-information-rfi_en.xlsxTue, 18 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/cvmp-june-2024-agenda-draft_en.pdfAgenda of the CVMP meeting 18-20 June 2024https://www.ema.europa.eu/system/files/documents/agenda/cvmp-june-2024-agenda-draft_en.pdfMon, 17 Jun 2024 16:31:08 +0200What's newhttps://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-14-june-2024_en.pdfCTIS newsflash – 14 June 2024https://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-14-june-2024_en.pdfMon, 17 Jun 2024 16:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/lotimaxVeterinary medicines European public assessment report (EPAR): Lotimax, lotilaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/lotimaxMon, 17 Jun 2024 16:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/lexylanVeterinary medicines European public assessment report (EPAR): Lexylan, Cefalexin, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/lexylanMon, 17 Jun 2024 15:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/verzeniosHuman medicines European public assessment report (EPAR): Verzenios, abemaciclib, Date of authorisation: 26/09/2018, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/verzeniosMon, 17 Jun 2024 15:44:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mounjaroHuman medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mounjaroMon, 17 Jun 2024 15:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/triloraleVeterinary medicines European public assessment report (EPAR): Trilorale, trilostane, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/triloraleMon, 17 Jun 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/invokanaHuman medicines European public assessment report (EPAR): Invokana, canagliflozin, Date of authorisation: 15/11/2013, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/invokanaMon, 17 Jun 2024 15:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vokanametHuman medicines European public assessment report (EPAR): Vokanamet, canagliflozin,metformin, Date of authorisation: 23/04/2014, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vokanametMon, 17 Jun 2024 15:38:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/trilocurVeterinary medicines European public assessment report (EPAR): Trilocur, trilostane, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/trilocurMon, 17 Jun 2024 15:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/wyostHuman medicines European public assessment report (EPAR): Wyost, denosumab, Date of authorisation: 17/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/wyostMon, 17 Jun 2024 14:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/recocamVeterinary medicines European public assessment report (EPAR): Recocam, meloxicam, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/recocamMon, 17 Jun 2024 14:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/forcerisVeterinary medicines European public assessment report (EPAR): Forceris, toltrazuril,iron (III) ion, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/forcerisMon, 17 Jun 2024 13:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/activylVeterinary medicines European public assessment report (EPAR): Activyl, indoxacarb, Status: Withdrawn (authorisation)https://www.ema.europa.eu/en/medicines/veterinary/EPAR/activylMon, 17 Jun 2024 13:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-blue-8Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine (inactivated) serotype 8, Status: Withdrawn (authorisation)https://www.ema.europa.eu/en/medicines/veterinary/EPAR/bovilis-blue-8Mon, 17 Jun 2024 11:54:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-pcwp-plenary-2-3-july-2024_en.pdfAgenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meetinghttps://www.ema.europa.eu/system/files/documents/agenda/draft-agenda-pcwp-plenary-2-3-july-2024_en.pdfMon, 17 Jun 2024 09:49:56 +0200What's newhttps://www.ema.europa.eu/en/events/small-medium-sized-enterprises-info-daySmall and medium-sized enterprises info day, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 October 2024, 09:30 (CEST) to 18 October 2024, 16:15 (CEST)https://www.ema.europa.eu/en/events/small-medium-sized-enterprises-info-dayMon, 17 Jun 2024 09:49:11 +0200What's newhttps://www.ema.europa.eu/en/events/meeting-ad-hoc-executive-steering-group-shortages-safety-medicinal-products-mssg-april-2024Meeting of the Ad-hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 April 2024, 09:00 (CEST) to 23 April 2024, 10:00 (CEST)https://www.ema.europa.eu/en/events/meeting-ad-hoc-executive-steering-group-shortages-safety-medicinal-products-mssg-april-2024Sun, 16 Jun 2024 14:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/tribuli-terrestris-herbaHerbal medicinal product: Tribuli terrestris herbaArray, D: Draft under discussionhttps://www.ema.europa.eu/en/medicines/herbal/tribuli-terrestris-herbaFri, 14 Jun 2024 17:35:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/tribulus-terrestris-ps-en.pdfDraft public statement on Tribulus terrestris L., herba - First versionhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/tribulus-terrestris-ps-en.pdfFri, 14 Jun 2024 17:31:55 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/urticae-radixHerbal medicinal product: Urticae radixArray,Array, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/urticae-radixFri, 14 Jun 2024 17:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/zingiberis-rhizomaHerbal medicinal product: Zingiberis rhizomaArray, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/zingiberis-rhizomaFri, 14 Jun 2024 17:25:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/zingiberis-rhizoma-mo-en.pdfDraft European Union herbal monograph on Zingiber officinale Roscoe, rhizoma - Revision 1https://www.ema.europa.eu/system/files/documents/herbal-monograph/zingiberis-rhizoma-mo-en.pdfFri, 14 Jun 2024 17:21:06 +0200What's newhttps://www.ema.europa.eu/system/files/documents/report/2023-aar-eu-bodies_and-publication_en.pdfAnnual activity report 2023https://www.ema.europa.eu/system/files/documents/report/2023-aar-eu-bodies_and-publication_en.pdfFri, 14 Jun 2024 17:09:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/herbal/urticae-herbaHerbal medicinal product: Urticae herbaArray,Array, F: Assessment finalisedhttps://www.ema.europa.eu/en/medicines/herbal/urticae-herbaFri, 14 Jun 2024 17:05:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bavencioHuman medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 18, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bavencioFri, 14 Jun 2024 17:03:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/urticae-herba-mo-en.pdfDraft European Union herbal monograph on Urtica dioica L.; Urtica urens L., herba - Revision 1https://www.ema.europa.eu/system/files/documents/herbal-monograph/urticae-herba-mo-en.pdfFri, 14 Jun 2024 16:30:05 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/prunus-avium-peduncle-mo-en.pdfDraft European Union herbal monograph on Prunus avium L.; Prunus cerasus L., peduncle - First versionhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/prunus-avium-peduncle-mo-en.pdfFri, 14 Jun 2024 16:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/metamizole-containing-medicinal-products-0Referral: Metamizole-containing medicinal products, metamizole Article 107i procedures Procedure startedhttps://www.ema.europa.eu/en/medicines/human/referrals/metamizole-containing-medicinal-products-0Fri, 14 Jun 2024 16:20:51 +0200What's newhttps://www.ema.europa.eu/en/news/review-painkiller-metamizole-startedReview of painkiller metamizole startedhttps://www.ema.europa.eu/en/news/review-painkiller-metamizole-startedFri, 14 Jun 2024 16:20:45 +0200What's newhttps://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-2024Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-2024Fri, 14 Jun 2024 16:20:00 +0200What's newhttps://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2024-meetingEMA Management Board: highlights of June 2024 meetinghttps://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2024-meetingFri, 14 Jun 2024 15:32:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-monograph/urticae-radix-mo-en.pdfDraft European Union herbal monograph on Urtica dioica L.; Urtica urens L., radix - Revision 1https://www.ema.europa.eu/system/files/documents/herbal-monograph/urticae-radix-mo-en.pdfFri, 14 Jun 2024 15:22:57 +0200What's newhttps://www.ema.europa.eu/system/files/documents/herbal-references/urticae-radix-lor-en.pdfDraft list of references supporting the assessment of Urtica dioica L.; Urtica urens L., radix - Revision 1https://www.ema.europa.eu/system/files/documents/herbal-references/urticae-radix-lor-en.pdfFri, 14 Jun 2024 15:21:36 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nezglyalHuman medicines European public assessment report (EPAR): Nezglyal, leriglitazone, Status: Opinionhttps://www.ema.europa.eu/en/medicines/human/EPAR/nezglyalFri, 14 Jun 2024 13:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/qalsodyHuman medicines European public assessment report (EPAR): Qalsody, Tofersen, Date of authorisation: 29/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/qalsodyFri, 14 Jun 2024 12:00:35 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/fabhaltaHuman medicines European public assessment report (EPAR): Fabhalta, Iptacopan, Date of authorisation: 17/05/2024, Revision: 0, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/fabhaltaFri, 14 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kisqaliHuman medicines European public assessment report (EPAR): Kisqali, ribociclib, Date of authorisation: 22/08/2017, Revision: 16, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kisqaliFri, 14 Jun 2024 11:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdivoHuman medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 60, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/opdivoFri, 14 Jun 2024 11:22:00 +0200What's newhttps://www.ema.europa.eu/en/events/executive-steering-group-shortages-safety-medicinal-products-mssg-meeting-april-2024Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meeting - April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 April 2024, 14:00 (CEST) to 12 April 2024, 16:00 (CEST)https://www.ema.europa.eu/en/events/executive-steering-group-shortages-safety-medicinal-products-mssg-meeting-april-2024Fri, 14 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-16-18-april-2024Committee for Orphan Medicinal Products (COMP): 16-18 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2024 to 18 April 2024https://www.ema.europa.eu/en/events/committee-orphan-medicinal-products-comp-16-18-april-2024Fri, 14 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tenkasiHuman medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Date of authorisation: 19/03/2015, Revision: 15, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tenkasiFri, 14 Jun 2024 11:00:00 +0200What's newhttps://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-real-world-evidence-rwe-methodsJoint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 June 2024, 09:00 (CEST) to 14 June 2024, 16:30 (CEST)https://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-real-world-evidence-rwe-methodsThu, 13 Jun 2024 17:00:34 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods-14-june-final-general_en.pdfAgenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methodshttps://www.ema.europa.eu/system/files/documents/agenda/agenda-joint-hma-ema-workshop-rwe-methods-14-june-final-general_en.pdfThu, 13 Jun 2024 17:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/kalydecoHuman medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Date of authorisation: 23/07/2012, Revision: 41, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kalydecoThu, 13 Jun 2024 16:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/suprelorinVeterinary medicines European public assessment report (EPAR): Suprelorin, deslorelin acetate, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/suprelorinThu, 13 Jun 2024 15:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/gumbohatchVeterinary medicines European public assessment report (EPAR): Gumbohatch, avian infectious bursal disease vaccine (live), Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/gumbohatchThu, 13 Jun 2024 15:34:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/melovemVeterinary medicines European public assessment report (EPAR): Melovem, meloxicam, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/melovemThu, 13 Jun 2024 15:24:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectra-3dVeterinary medicines European public assessment report (EPAR): Vectra 3D, dinotefuran, permethrin, and pyriproxyfen, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/vectra-3dThu, 13 Jun 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparica-trioVeterinary medicines European public assessment report (EPAR): Simparica Trio, sarolaner,moxidectin,pyrantel embonate, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparica-trioThu, 13 Jun 2024 13:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/coxevacVeterinary medicines European public assessment report (EPAR): Coxevac, inactivated Coxiella burnetii vaccine, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/coxevacThu, 13 Jun 2024 13:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgard-spectraVeterinary medicines European public assessment report (EPAR): Nexgard Spectra, afoxolaner,milbemycin oxime, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgard-spectraThu, 13 Jun 2024 13:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgardVeterinary medicines European public assessment report (EPAR): NexGard, afoxolaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/nexgardThu, 13 Jun 2024 12:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bluevac-btv-previously-known-bluevac-btv8Veterinary medicines European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8), Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bluevac-btv-previously-known-bluevac-btv8Thu, 13 Jun 2024 12:27:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/article-57-product-data_en_4.xlsxArticle 57 product datahttps://www.ema.europa.eu/system/files/documents/other/article-57-product-data_en_4.xlsxThu, 13 Jun 2024 11:38:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-124th-meeting-ema-management-board_en_0.pdfAgenda of the 124th meeting of the Management Board : 12-13 June 2024https://www.ema.europa.eu/system/files/documents/agenda/agenda-124th-meeting-ema-management-board_en_0.pdfThu, 13 Jun 2024 11:26:45 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/iris-guide-applicants_en_1.pdfIRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicantshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/iris-guide-applicants_en_1.pdfThu, 13 Jun 2024 10:45:00 +0200What's newhttps://www.ema.europa.eu/en/variations-guidelines-proposed-amendments-european-commission-guidelines-variations-categories-proceduresVariations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedureshttps://www.ema.europa.eu/en/variations-guidelines-proposed-amendments-european-commission-guidelines-variations-categories-proceduresThu, 13 Jun 2024 09:45:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/proposed-revision-track-changes-european-commission-guidelines-categories-variations-2013-c-223-01-_13_en_0.pdfEuropean Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - track changeshttps://www.ema.europa.eu/system/files/documents/other/proposed-revision-track-changes-european-commission-guidelines-categories-variations-2013-c-223-01-_13_en_0.pdfThu, 13 Jun 2024 09:44:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/variations-guidelines_executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_13-june-2024_en.pdfExecutive summary for proposed amendments to the European Commission guidelines on variations categories and procedureshttps://www.ema.europa.eu/system/files/documents/other/variations-guidelines_executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_13-june-2024_en.pdfThu, 13 Jun 2024 09:43:00 +0200What's newhttps://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database/union-product-database-release-notesUnion Product Database: release noteshttps://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database/union-product-database-release-notesThu, 13 Jun 2024 09:31:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/avian-influenza-bird-fluAvian influenza (bird flu)https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/avian-influenza-bird-fluWed, 12 Jun 2024 16:37:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/agenda-biannual-bdsg-industry-stakeholders-meeting-23-may-2024_en.pdfAgenda - Biannual Big Data Steering Group and industry stakeholders meeting 2024https://www.ema.europa.eu/system/files/documents/agenda/agenda-biannual-bdsg-industry-stakeholders-meeting-23-may-2024_en.pdfWed, 12 Jun 2024 16:20:00 +0200What's newhttps://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-partyMedicine Shortages Single Point of Contact (SPOC) Working Partyhttps://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-partyWed, 12 Jun 2024 15:42:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/chmp-annex/overview-invented-names-reviewed-16-april-2024_en.pdfOverview of (invented) names reviewed in April 2024 by the Name Review Group (NRG) adopted at the CHMP meeting of 27-30 May 2024https://www.ema.europa.eu/system/files/documents/chmp-annex/overview-invented-names-reviewed-16-april-2024_en.pdfWed, 12 Jun 2024 15:40:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/network_portfolio_roadmap_en.pdfNetwork Portfolio Roadmaphttps://www.ema.europa.eu/system/files/documents/other/network_portfolio_roadmap_en.pdfWed, 12 Jun 2024 15:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xenpozymeHuman medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xenpozymeWed, 12 Jun 2024 15:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/ozempicHuman medicines European public assessment report (EPAR): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/ozempicWed, 12 Jun 2024 15:11:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/240612-minimum-inhibitory-concentration-mic-breakpoints_en.xlsxMinimum inhibitory concentration (MIC) breakpointshttps://www.ema.europa.eu/system/files/documents/other/240612-minimum-inhibitory-concentration-mic-breakpoints_en.xlsxWed, 12 Jun 2024 15:10:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/wegovyHuman medicines European public assessment report (EPAR): Wegovy, semaglutide, Date of authorisation: 06/01/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/wegovyWed, 12 Jun 2024 14:55:00 +0200What's newhttps://www.ema.europa.eu/en/events/enpr-ema-coordinating-group-meeting-june-2024Enpr-EMA Coordinating Group meeting June 2024, European Medicines Agency, Amsterdam, the Netherlands, 12 June 2024https://www.ema.europa.eu/en/events/enpr-ema-coordinating-group-meeting-june-2024Wed, 12 Jun 2024 14:44:28 +0200What's newhttps://www.ema.europa.eu/en/events/information-session-pilot-expert-panels-scientific-advice-manufacturers-high-risk-medical-devicesInformation session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices, Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 January 2023, 14:00 (CET) to 25 January 2023, 15:30 (CET)https://www.ema.europa.eu/en/events/information-session-pilot-expert-panels-scientific-advice-manufacturers-high-risk-medical-devicesWed, 12 Jun 2024 14:39:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/aubagioHuman medicines European public assessment report (EPAR): Aubagio, teriflunomide, Date of authorisation: 26/08/2013, Revision: 27, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/aubagioWed, 12 Jun 2024 14:11:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cervarixHuman medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), Date of authorisation: 20/09/2007, Revision: 39, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cervarixWed, 12 Jun 2024 13:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsiHuman medicines European public assessment report (EPAR): Pedmarqsi, sodium thiosulfate, Date of authorisation: 26/05/2023, Revision: 3, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsiWed, 12 Jun 2024 13:16:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/opfoldaHuman medicines European public assessment report (EPAR): Opfolda, miglustat, Date of authorisation: 26/06/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/opfoldaWed, 12 Jun 2024 12:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/comirnatyHuman medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,raxtozinameran, Date of authorisation: 21/12/2020, Revision: 47, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/comirnatyWed, 12 Jun 2024 12:34:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/priority-list-may-2024_en.pdfHMPC: overview of assessment work - priority listhttps://www.ema.europa.eu/system/files/documents/other/priority-list-may-2024_en.pdfWed, 12 Jun 2024 12:28:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/cat-minutes-17-19-january-2024-rev1_en.pdfMinutes of the CAT meeting 17-19 January 2024https://www.ema.europa.eu/system/files/documents/minutes/cat-minutes-17-19-january-2024-rev1_en.pdfWed, 12 Jun 2024 12:23:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-08-11-april-2024-publication_en.pdfMinutes of the PRAC meeting 8-11 April 2024https://www.ema.europa.eu/system/files/documents/minutes/minutes-prac-meeting-08-11-april-2024-publication_en.pdfWed, 12 Jun 2024 12:17:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/chmp-minutes-annex-18-21-march-2024_for-publication_en.pdfMinutes of the CHMP meeting 18-21 March 2024https://www.ema.europa.eu/system/files/documents/minutes/chmp-minutes-annex-18-21-march-2024_for-publication_en.pdfWed, 12 Jun 2024 12:10:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/prom-minutes-11-march-2024-publication_en.pdfCHMP PROM minutes for the meeting on 11 March 2024https://www.ema.europa.eu/system/files/documents/minutes/prom-minutes-11-march-2024-publication_en.pdfWed, 12 Jun 2024 11:59:20 +0200What's newhttps://www.ema.europa.eu/en/events/third-european-medicines-agency-ema-medtech-europe-bilateral-meetingThird European Medicines Agency (EMA) and MedTech Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 July 2024https://www.ema.europa.eu/en/events/third-european-medicines-agency-ema-medtech-europe-bilateral-meetingWed, 12 Jun 2024 11:49:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/summary-medicine-shortages-spoc-working-party-meeting-15-16-april-2024_en.pdfMeeting Summary - Medicine Shortages Single Point of Contact (SPOC) Working Party - 15-16 April 2024https://www.ema.europa.eu/system/files/documents/minutes/summary-medicine-shortages-spoc-working-party-meeting-15-16-april-2024_en.pdfWed, 12 Jun 2024 11:05:00 +0200What's newhttps://www.ema.europa.eu/en/events/committee-herbal-medicinal-products-hmpc-18-20-march-2024Committee for Herbal Medicinal Products (HMPC): 18-20 March 2024, European Medicines Agency, Amsterdam, the Netherlands, from 18 March 2024 to 20 March 2024https://www.ema.europa.eu/en/events/committee-herbal-medicinal-products-hmpc-18-20-march-2024Wed, 12 Jun 2024 10:32:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/hmpc-minutes-18-20-march-2024_en.pdfMinutes of the HMPC meeting 18-20 March 2024https://www.ema.europa.eu/system/files/documents/minutes/hmpc-minutes-18-20-march-2024_en.pdfWed, 12 Jun 2024 10:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/imfinziHuman medicines European public assessment report (EPAR): Imfinzi, durvalumab, Date of authorisation: 21/09/2018, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/imfinziWed, 12 Jun 2024 10:18:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/solirisHuman medicines European public assessment report (EPAR): Soliris, eculizumab, Date of authorisation: 20/06/2007, Revision: 37, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/solirisWed, 12 Jun 2024 09:56:00 +0200What's newhttps://www.ema.europa.eu/en/events/fourth-european-medicines-agency-nuclear-medicines-europe-bilateral-meetingFourth European Medicines Agency and Nuclear Medicines Europe bilateral meeting, Online, 14 June 2024https://www.ema.europa.eu/en/events/fourth-european-medicines-agency-nuclear-medicines-europe-bilateral-meetingWed, 12 Jun 2024 09:50:00 +0200What's newhttps://www.ema.europa.eu/en/events/product-management-service-pms-product-ui-api-training-access-navigationProduct Management Service (PMS) Product UI training (access & navigation), Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 10:00 (CEST) to 3 June 2024, 11:30 (CEST)https://www.ema.europa.eu/en/events/product-management-service-pms-product-ui-api-training-access-navigationWed, 12 Jun 2024 09:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/glyxambiHuman medicines European public assessment report (EPAR): Glyxambi, empagliflozin,linagliptin, Date of authorisation: 11/11/2016, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/glyxambiTue, 11 Jun 2024 16:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plusVeterinary medicines European public assessment report (EPAR): Credelio Plus, lotilaner / milbemycin oxime, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plusTue, 11 Jun 2024 15:47:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler-previously-budesonide-formoterol-teva-pharma-bvHuman medicines European public assessment report (EPAR): GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.), budesonide,formoterol fumarate dihydrate, Date of authorisation: 03/04/2020, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler-previously-budesonide-formoterol-teva-pharma-bvTue, 11 Jun 2024 15:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pyzchivaHuman medicines European public assessment report (EPAR): Pyzchiva, ustekinumab, Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pyzchivaTue, 11 Jun 2024 15:33:00 +0200What's newhttps://www.ema.europa.eu/en/events/third-listen-learn-focus-group-meeting-quality-innovation-groupThird listen-and-learn focus group meeting of the Quality Innovation Group, European Medicines Agency, Amsterdam, the Netherlands, from 4 June 2024 to 5 June 2024https://www.ema.europa.eu/en/events/third-listen-learn-focus-group-meeting-quality-innovation-groupTue, 11 Jun 2024 14:03:00 +0200What's newhttps://www.ema.europa.eu/en/events/european-shortages-monitoring-platform-essentials-industry-reporting-requirementsEuropean Shortages Monitoring Platform Essentials and Industry Reporting Requirements, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 June 2024, 10:00 (CEST) to 24 June 2024, 12:30 (CEST)https://www.ema.europa.eu/en/events/european-shortages-monitoring-platform-essentials-industry-reporting-requirementsTue, 11 Jun 2024 13:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/mipet-easectoVeterinary medicines European public assessment report (EPAR): MiPet Easecto, sarolaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/mipet-easectoTue, 11 Jun 2024 13:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparicaVeterinary medicines European public assessment report (EPAR): Simparica, sarolaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/simparicaTue, 11 Jun 2024 13:01:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/hexyonHuman medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 31, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/hexyonTue, 11 Jun 2024 12:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/hexacimaHuman medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/hexacimaTue, 11 Jun 2024 12:07:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/veltassaHuman medicines European public assessment report (EPAR): Veltassa, patiromer, Date of authorisation: 19/07/2017, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/veltassaTue, 11 Jun 2024 11:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/litfuloHuman medicines European public assessment report (EPAR): Litfulo, ritlecitinib, Date of authorisation: 15/09/2023, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/litfuloTue, 11 Jun 2024 11:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/improvacVeterinary medicines European public assessment report (EPAR): Improvac, Gonadotropin releasing factor (GnRF) analogue-protein conjugate, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/improvacTue, 11 Jun 2024 11:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/vumerityHuman medicines European public assessment report (EPAR): Vumerity, diroximel fumarate, Date of authorisation: 15/11/2021, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/vumerityTue, 11 Jun 2024 11:46:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/micrazym-associated-namesReferral: Micrazym and associated names, porcine pancreas enzymes Article 29(4) referrals European Commission final decision, 21/03/2024, 16/05/2024, 11/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/micrazym-associated-namesTue, 11 Jun 2024 11:37:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/respivac-trtVeterinary medicines European public assessment report (EPAR): Respivac TRT, Turkey rhinotracheitis virus, strain 1062, live, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/respivac-trtTue, 11 Jun 2024 11:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/libmyrisHuman medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/libmyrisTue, 11 Jun 2024 09:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovidHuman medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovidTue, 11 Jun 2024 09:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/respreezaHuman medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Date of authorisation: 20/08/2015, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/respreezaMon, 10 Jun 2024 16:06:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zykadiaHuman medicines European public assessment report (EPAR): Zykadia, ceritinib, Date of authorisation: 06/05/2015, Revision: 20, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zykadiaMon, 10 Jun 2024 15:55:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/agenda/prac-agenda-10-13-june-2024-publication_en.pdfAgenda of the PRAC meeting 10-13 June 2024https://www.ema.europa.eu/system/files/documents/agenda/prac-agenda-10-13-june-2024-publication_en.pdfMon, 10 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/4a-hv-survey-pharmacovigilance-contact-person-national-level_en.pdfInformation on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national levelhttps://www.ema.europa.eu/system/files/documents/other/4a-hv-survey-pharmacovigilance-contact-person-national-level_en.pdfMon, 10 Jun 2024 15:18:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/minutes/final-minutes-big-data-steering-group-22-april-2024_en.pdfFinal Minutes – HMA-EMA joint Big Data Steering Group teleconference - 22 April 2024https://www.ema.europa.eu/system/files/documents/minutes/final-minutes-big-data-steering-group-22-april-2024_en.pdfMon, 10 Jun 2024 15:07:37 +0200What's newhttps://www.ema.europa.eu/en/events/follow-ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaFollow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma, Online, European Medicines Agency, Amsterdam, the Netherlands, 24 May 2024https://www.ema.europa.eu/en/events/follow-ema-eortc-multi-stakeholder-workshop-soft-tissue-bone-sarcomaMon, 10 Jun 2024 15:03:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/intunivHuman medicines European public assessment report (EPAR): Intuniv, guanfacine, Date of authorisation: 17/09/2015, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/intunivMon, 10 Jun 2024 14:58:00 +0200What's newhttps://www.ema.europa.eu/en/news/two-new-advice-pilots-improve-clinical-trials-europeTwo new advice pilots to improve clinical trials in Europehttps://www.ema.europa.eu/en/news/two-new-advice-pilots-improve-clinical-trials-europeMon, 10 Jun 2024 12:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/questions-answers-tailored-scientific-advice-support-step-step-development-new-biosimilars_en.pdfQuestions and Answers on the tailored scientific advice to support step-by-step development of new biosimilarshttps://www.ema.europa.eu/system/files/documents/other/questions-answers-tailored-scientific-advice-support-step-step-development-new-biosimilars_en.pdfMon, 10 Jun 2024 12:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/prac-recommendation/new-product-information-wording-may-2024_en_0.pdfNew product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAChttps://www.ema.europa.eu/system/files/documents/prac-recommendation/new-product-information-wording-may-2024_en_0.pdfMon, 10 Jun 2024 10:40:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2024-prac_en_0.pdfPRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meetinghttps://www.ema.europa.eu/system/files/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2024-prac_en_0.pdfMon, 10 Jun 2024 10:36:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_6.xlsxList of signals discussed at PRAC since September 2012https://www.ema.europa.eu/system/files/documents/other/list-signals-discussed-prac-september-2012_en_6.xlsxMon, 10 Jun 2024 10:33:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003184-pip01-22EMEA-003184-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003184-pip01-22Fri, 07 Jun 2024 17:17:36 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003080-pip03-22EMEA-003080-PIP03-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003080-pip03-22Fri, 07 Jun 2024 16:38:58 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/change-management-activities-delivery-plan_en.pdfChange management activities delivery planhttps://www.ema.europa.eu/system/files/documents/other/change-management-activities-delivery-plan_en.pdfFri, 07 Jun 2024 15:34:50 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002612-pip02-22EMEA-002612-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002612-pip02-22Fri, 07 Jun 2024 15:08:37 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003079-pip01-22Opinion/decision on a Paediatric investigation plan (PIP): Evusheld, tixagevimab,cilgavimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Infectious diseases, PIP number: P/0119/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003079-pip01-22Fri, 07 Jun 2024 15:03:01 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1199Orphan designation: Sorafenib tosilate Treatment of follicular thyroid cancer, 13/11/2013 Expiredhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1199Fri, 07 Jun 2024 14:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1200Orphan designation: Sorafenib tosilate Treatment of papillary thyroid cancer, 13/11/2013 Expiredhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1200Fri, 07 Jun 2024 14:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/nexavarHuman medicines European public assessment report (EPAR): Nexavar, sorafenib, Date of authorisation: 19/07/2006, Revision: 33, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/nexavarFri, 07 Jun 2024 14:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-07-508Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) Treatment of Castleman's disease, 30/11/2007 Expiredhttps://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-07-508Fri, 07 Jun 2024 14:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sylvantHuman medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sylvantFri, 07 Jun 2024 14:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/lamivudine-tevaHuman medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Date of authorisation: 23/10/2009, Revision: 14, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/lamivudine-tevaFri, 07 Jun 2024 14:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-zentivaHuman medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine,tenofovir disoproxil, Date of authorisation: 09/11/2016, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-zentivaFri, 07 Jun 2024 14:53:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000032-pip02-22Opinion/decision on a Paediatric investigation plan (PIP): Menveo, Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM), decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Vaccines, PIP number: P/0116/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000032-pip02-22Fri, 07 Jun 2024 14:25:54 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-hydrochlorothiazide-tevaHuman medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan,hydrochlorothiazide, Date of authorisation: 26/11/2009, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/irbesartan-hydrochlorothiazide-tevaFri, 07 Jun 2024 13:58:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003370-pip01-22EMEA-003370-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003370-pip01-22Fri, 07 Jun 2024 12:23:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003364-pip02-22EMEA-003364-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003364-pip02-22Fri, 07 Jun 2024 12:22:36 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003339-pip02-23EMEA-003339-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003339-pip02-23Fri, 07 Jun 2024 12:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003302-pip01-22EMEA-003302-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003302-pip01-22Fri, 07 Jun 2024 12:07:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003279-pip01-22EMEA-003279-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003279-pip01-22Fri, 07 Jun 2024 12:05:32 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003251-pip01-22EMEA-003251-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003251-pip01-22Fri, 07 Jun 2024 12:02:58 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003208-pip02-22EMEA-003208-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003208-pip02-22Fri, 07 Jun 2024 11:55:36 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001231-pip02-13-m10EMEA-001231-PIP02-13-M10https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001231-pip02-13-m10Fri, 07 Jun 2024 11:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001523-pip04-19-m02Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, Guselkumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0190/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001523-pip04-19-m02Fri, 07 Jun 2024 11:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001490-pip01-13-m04Opinion/decision on a Paediatric investigation plan (PIP): Vaxchora, Cholera vaccine, live attenuated, oral (strain CVD 103-HgR), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0189/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001490-pip01-13-m04Fri, 07 Jun 2024 11:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001238-pip03-21-m01EMEA-001238-PIP03-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001238-pip03-21-m01Fri, 07 Jun 2024 11:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/parsabivHuman medicines European public assessment report (EPAR): Parsabiv, etelcalcetide, Date of authorisation: 11/11/2016, Revision: 10, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/parsabivFri, 07 Jun 2024 11:03:00 +0200What's newhttps://www.ema.europa.eu/en/events/methodology-working-party-interested-parties-meetingMethodology Working Party Interested Parties Meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 June 2024, 09:00 (CEST) to 7 June 2024, 13:00 (CEST)https://www.ema.europa.eu/en/events/methodology-working-party-interested-parties-meetingFri, 07 Jun 2024 10:40:34 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001214-pip09-21-m01Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0173/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001214-pip09-21-m01Thu, 06 Jun 2024 15:54:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001194-pip01-11-m06Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0172/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001194-pip01-11-m06Thu, 06 Jun 2024 15:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001075-pip04-15-m06Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0171/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001075-pip04-15-m06Thu, 06 Jun 2024 15:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000973-pip01-10-m04Opinion/decision on a Paediatric investigation plan (PIP): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0170/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000973-pip01-10-m04Thu, 06 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000353-pip02-16-m03Opinion/decision on a Paediatric investigation plan (PIP): Livtencity, Maribavir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0183/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000353-pip02-16-m03Thu, 06 Jun 2024 15:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000115-pip01-07-m13Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0196/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000115-pip01-07-m13Thu, 06 Jun 2024 15:14:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/skyclarysHuman medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Date of authorisation: 09/02/2024, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/skyclarysThu, 06 Jun 2024 14:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rizmoicHuman medicines European public assessment report (EPAR): Rizmoic, naldemedine, Date of authorisation: 18/02/2019, Revision: 11, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rizmoicThu, 06 Jun 2024 14:45:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/hizentraHuman medicines European public assessment report (EPAR): Hizentra, human normal immunoglobulin (SCIg), Date of authorisation: 14/04/2011, Revision: 24, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/hizentraThu, 06 Jun 2024 14:40:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-sunHuman medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Sun, sitagliptin,metformin hydrochloride, Date of authorisation: 31/03/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-sunThu, 06 Jun 2024 13:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/byfavoHuman medicines European public assessment report (EPAR): Byfavo, remimazolam, Date of authorisation: 26/03/2021, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/byfavoThu, 06 Jun 2024 13:26:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/tysabriHuman medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 45, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/tysabriThu, 06 Jun 2024 13:13:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/mimparaHuman medicines European public assessment report (EPAR): Mimpara, cinacalcet, Date of authorisation: 22/10/2004, Revision: 26, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/mimparaThu, 06 Jun 2024 13:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/jubbontiHuman medicines European public assessment report (EPAR): Jubbonti, denosumab, Date of authorisation: 16/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/jubbontiThu, 06 Jun 2024 12:53:00 +0200What's newhttps://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsEMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)https://www.ema.europa.eu/en/events/ema-fve-info-session-restrictions-use-certain-antimicrobials-animalsThu, 06 Jun 2024 11:10:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/138-eurd-list-publication-5-june-2024_new-revision_en.xlsxList of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)https://www.ema.europa.eu/system/files/documents/other/138-eurd-list-publication-5-june-2024_new-revision_en.xlsxThu, 06 Jun 2024 11:09:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overviewPharmacovigilance: Overviewhttps://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overviewThu, 06 Jun 2024 10:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/qdengaHuman medicines European public assessment report (EPAR): Qdenga, dengue tetravalent vaccine (live, attenuated), Date of authorisation: 05/12/2022, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/qdengaThu, 06 Jun 2024 10:52:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/impact-research-projects_en.pdfResearch projects conducted under the remit of the PRAC impact strategyhttps://www.ema.europa.eu/system/files/documents/other/impact-research-projects_en.pdfThu, 06 Jun 2024 10:52:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/enbrelHuman medicines European public assessment report (EPAR): Enbrel, etanercept, Date of authorisation: 02/02/2000, Revision: 74, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/enbrelThu, 06 Jun 2024 09:50:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/trodelvyHuman medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Date of authorisation: 22/11/2021, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/trodelvyThu, 06 Jun 2024 09:21:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/myocet-liposomal-previously-myocetHuman medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin, Date of authorisation: 13/07/2000, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/myocet-liposomal-previously-myocetThu, 06 Jun 2024 09:17:07 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/giaprezaHuman medicines European public assessment report (EPAR): Giapreza, angiotensin II, Date of authorisation: 23/08/2019, Revision: 4, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/giaprezaThu, 06 Jun 2024 09:06:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/vaccine-monitoring-platformVaccine Monitoring Platformhttps://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/vaccine-monitoring-platformWed, 05 Jun 2024 16:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/dhpc/kexxtoneKexxtonehttps://www.ema.europa.eu/en/medicines/dhpc/kexxtoneWed, 05 Jun 2024 16:28:37 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/reyatazHuman medicines European public assessment report (EPAR): Reyataz, atazanavir sulfate, Date of authorisation: 01/03/2004, Revision: 55, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/reyatazWed, 05 Jun 2024 16:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/erbituxHuman medicines European public assessment report (EPAR): Erbitux, cetuximab, Date of authorisation: 29/06/2004, Revision: 30, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/erbituxWed, 05 Jun 2024 16:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/beyfortusHuman medicines European public assessment report (EPAR): Beyfortus, nirsevimab, Date of authorisation: 31/10/2022, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/beyfortusWed, 05 Jun 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/pecfentHuman medicines European public assessment report (EPAR): PecFent, fentanyl, Date of authorisation: 31/08/2010, Revision: 25, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/pecfentWed, 05 Jun 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/shortage/salbutamol-inhalation-products-shortage-catalogue-entry_en.pdfSalbutamol inhalation products suppy shortagehttps://www.ema.europa.eu/system/files/documents/shortage/salbutamol-inhalation-products-shortage-catalogue-entry_en.pdfWed, 05 Jun 2024 14:58:23 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/synapseReferral: Synapse Article 31 referrals European Commission final decision, 21/03/2024, 24/05/2024, 05/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/synapseWed, 05 Jun 2024 14:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/ibuprofen-nvtReferral: Ibuprofen NVT, ibuprofen Article 29(4) referrals European Commission final decision, 22/02/2024, 10/05/2024, 05/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/ibuprofen-nvtWed, 05 Jun 2024 13:55:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/alprolixHuman medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Date of authorisation: 12/05/2016, Revision: 9, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/alprolixWed, 05 Jun 2024 13:53:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-training-supportEudraVigilance training and supporthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-training-supportWed, 05 Jun 2024 13:06:00 +0200What's newhttps://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-43Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 2 December 2024 to 6 December 2024https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-43Wed, 05 Jun 2024 12:31:00 +0200What's newhttps://www.ema.europa.eu/en/events/virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-11Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 26 November 2024 to 28 November 2024https://www.ema.europa.eu/en/events/virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-11Wed, 05 Jun 2024 12:30:01 +0200What's newhttps://www.ema.europa.eu/en/events/virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-10Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 7 October 2024 to 9 October 2024https://www.ema.europa.eu/en/events/virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-10Wed, 05 Jun 2024 12:30:01 +0200What's newhttps://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-44Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 4 November 2024 to 8 November 2024https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-44Wed, 05 Jun 2024 12:30:01 +0200What's newhttps://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-45Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 14 October 2024 to 18 October 2024https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-45Wed, 05 Jun 2024 12:30:01 +0200What's newhttps://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-42Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 16 September 2024 to 20 September 2024https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-42Wed, 05 Jun 2024 12:30:01 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/abilify-maintenaHuman medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 22, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/abilify-maintenaWed, 05 Jun 2024 11:36:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicinesPRIME: priority medicineshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicinesWed, 05 Jun 2024 10:35:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-may-2024_en.xlsxList of medicines currently in PRIME schemehttps://www.ema.europa.eu/system/files/documents/other/list-prime-products-may-2024_en.xlsxWed, 05 Jun 2024 09:42:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/application-form-european-medicines-agency-certificates-medicinal-products_en_1.pdfApplication form for European Medicines Agency certificates of medicinal productshttps://www.ema.europa.eu/system/files/documents/template-form/application-form-european-medicines-agency-certificates-medicinal-products_en_1.pdfWed, 05 Jun 2024 09:07:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xromiHuman medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Date of authorisation: 01/07/2019, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xromiTue, 04 Jun 2024 16:00:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en_0.pdfProcedural advice on paediatric applicationshttps://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en_0.pdfTue, 04 Jun 2024 14:12:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/oxbrytaHuman medicines European public assessment report (EPAR): Oxbryta, Voxelotor, Date of authorisation: 14/02/2022, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/oxbrytaTue, 04 Jun 2024 13:56:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/onpattroHuman medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 13, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/onpattroTue, 04 Jun 2024 13:06:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/suliquaHuman medicines European public assessment report (EPAR): Suliqua, insulin glargine,lixisenatide, Date of authorisation: 11/01/2017, Revision: 12, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/suliquaTue, 04 Jun 2024 12:57:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xultophyHuman medicines European public assessment report (EPAR): Xultophy, insulin degludec,liraglutide, Date of authorisation: 18/09/2014, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xultophyTue, 04 Jun 2024 12:55:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/5-snsa-application-form-snsa-pre-cta-advice_en_0.docxApplication form to request Simultaneous National Scientific Advice (SNSA) or a pre-CTA Advicehttps://www.ema.europa.eu/system/files/documents/template-form/5-snsa-application-form-snsa-pre-cta-advice_en_0.docxTue, 04 Jun 2024 12:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/referrals/kexxtone-324-g-continuous-release-intraruminal-device-cattleReferral: Kexxtone 32.4 g continuous-release intraruminal device for cattle, monensin Article 130(4) European Commission final decision, 23/04/2024, 15/05/2024https://www.ema.europa.eu/en/medicines/veterinary/referrals/kexxtone-324-g-continuous-release-intraruminal-device-cattleTue, 04 Jun 2024 09:52:52 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelioVeterinary medicines European public assessment report (EPAR): Credelio, lotilaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelioMon, 03 Jun 2024 22:31:00 +0200What's newhttps://www.ema.europa.eu/en/news/eu-recommendations-2024-2025-seasonal-flu-vaccine-compositionEU recommendations for 2024/2025 seasonal flu vaccine compositionhttps://www.ema.europa.eu/en/news/eu-recommendations-2024-2025-seasonal-flu-vaccine-compositionMon, 03 Jun 2024 17:57:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/annual-report/2023-annual-report-european-medicines-agency_en.pdf2023 annual report of the European Medicines Agencyhttps://www.ema.europa.eu/system/files/documents/annual-report/2023-annual-report-european-medicines-agency_en.pdfMon, 03 Jun 2024 17:40:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/other/1-snsa-procedure-applicants-update_en.pdfGuidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized processhttps://www.ema.europa.eu/system/files/documents/other/1-snsa-procedure-applicants-update_en.pdfMon, 03 Jun 2024 17:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/referrals/ocalivaReferral: Ocaliva, obeticholic acid Article 20 procedures Under evaluation, 03/06/2024https://www.ema.europa.eu/en/medicines/human/referrals/ocalivaMon, 03 Jun 2024 16:45:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/class-waiversClass waivershttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/class-waiversMon, 03 Jun 2024 16:13:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/annual-report-deferralsAnnual report on deferralshttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/annual-report-deferralsMon, 03 Jun 2024 16:12:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plansPaediatric investigation planshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plansMon, 03 Jun 2024 16:08:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-questions-answersPaediatric investigation plans: questions and answershttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-questions-answersMon, 03 Jun 2024 16:02:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-templates-formsPaediatric investigation plans: Templates and formshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-templates-formsMon, 03 Jun 2024 15:59:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overviewPaediatric medicines: Overviewhttps://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overviewMon, 03 Jun 2024 15:56:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-developmentPaediatric medicines: Research and developmenthttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-developmentMon, 03 Jun 2024 15:54:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-proceduresPaediatric medicines: applications and procedureshttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-proceduresMon, 03 Jun 2024 15:49:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/xareltoHuman medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Date of authorisation: 30/09/2008, Revision: 41, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/xareltoMon, 03 Jun 2024 15:38:00 +0200What's newhttps://www.ema.europa.eu/en/about-us/who-we-are/information-managementInformation Managementhttps://www.ema.europa.eu/en/about-us/who-we-are/information-managementMon, 03 Jun 2024 15:30:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/template-compliance-check_en.docxTemplate - Request for compliance check on an agreed paediatric investigation plan (PIP)https://www.ema.europa.eu/system/files/documents/template-form/template-compliance-check_en.docxMon, 03 Jun 2024 15:17:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/dacogenHuman medicines European public assessment report (EPAR): Dacogen, decitabine, Date of authorisation: 20/09/2012, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/dacogenMon, 03 Jun 2024 15:15:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003371-pip01-22EMEA-003371-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003371-pip01-22Mon, 03 Jun 2024 15:14:54 +0200What's newhttps://www.ema.europa.eu/system/files/documents/template-form/template-scientific-document_en.docxTemplate for scientific documenthttps://www.ema.europa.eu/system/files/documents/template-form/template-scientific-document_en.docxMon, 03 Jun 2024 15:02:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/somakit-tocHuman medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Date of authorisation: 08/12/2016, Revision: 17, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/somakit-tocMon, 03 Jun 2024 14:48:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/sunitinib-accordHuman medicines European public assessment report (EPAR): Sunitinib Accord, sunitinib, Date of authorisation: 11/02/2021, Revision: 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/sunitinib-accordMon, 03 Jun 2024 14:32:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/suboxoneHuman medicines European public assessment report (EPAR): Suboxone, buprenorphine,naloxone, Date of authorisation: 26/09/2006, Revision: 23, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/suboxoneMon, 03 Jun 2024 14:20:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/filspariHuman medicines European public assessment report (EPAR): Filspari, Sparsentan, Date of authorisation: 19/04/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/filspariMon, 03 Jun 2024 14:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/circovacVeterinary medicines European public assessment report (EPAR): Circovac, adjuvanted inactivated vaccine against porcine circovirus type 2, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/circovacMon, 03 Jun 2024 14:19:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/awiqliHuman medicines European public assessment report (EPAR): Awiqli, Insulin icodec, Date of authorisation: 17/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/awiqliMon, 03 Jun 2024 14:15:00 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors/recommendations-medication-errorsRecommendations on medication errorshttps://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors/recommendations-medication-errorsMon, 03 Jun 2024 13:08:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravectoVeterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/bravectoMon, 03 Jun 2024 12:28:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/imjudoHuman medicines European public assessment report (EPAR): Imjudo, tremelimumab, Date of authorisation: 20/02/2023, Revision: 5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/imjudoMon, 03 Jun 2024 11:42:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimervaxHuman medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted),selvacovatein, Date of authorisation: 30/03/2023, Revision: 6, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/bimervaxMon, 03 Jun 2024 11:36:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/cufenceHuman medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 7, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/cufenceMon, 03 Jun 2024 11:35:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/zilbrysqHuman medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Revision: 1, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/zilbrysqMon, 03 Jun 2024 11:25:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-h5Veterinary medicines European public assessment report (EPAR): Innovax-ND-H5, Turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of Avian influenza virus subtype H5, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/veterinary/EPAR/innovax-nd-h5Mon, 03 Jun 2024 10:30:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrekHuman medicines European public assessment report (EPAR): Rozlytrek, entrectinib, Date of authorisation: 31/07/2020, Revision: 8, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrekMon, 03 Jun 2024 10:00:00 +0200What's newhttps://www.ema.europa.eu/en/medicines/human/EPAR/omlycloHuman medicines European public assessment report (EPAR): Omlyclo, omalizumab, Date of authorisation: 16/05/2024, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/omlycloMon, 03 Jun 2024 09:48:00 +0200What's newhttps://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-31-may-2024_en.pdfCTIS newsflash - 31 May 2024https://www.ema.europa.eu/system/files/documents/newsletter/ctis-newsflash-31-may-2024_en.pdfMon, 03 Jun 2024 09:44:01 +0200What's newhttps://www.ema.europa.eu/system/files/documents/shortage/immunoglobulins-shortage-en.pdfShortage of human normal immunoglobulinshttps://www.ema.europa.eu/system/files/documents/shortage/immunoglobulins-shortage-en.pdfMon, 03 Jun 2024 09:27:40 +0200What's newhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/removing-orphan-designationRemoving an orphan designationhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/removing-orphan-designationMon, 03 Jun 2024 09:02:00 +0200What's new