30/04/2024 | Document: Minutes of the CAT meeting 14-16 February 2024 | New |
30/04/2024 | Document: CAT meetings in 2025 and 2026 | New |
30/04/2024 | Page: Resources for healthcare professionals | Updated |
30/04/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024 | Updated |
30/04/2024 | Document: Ketoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limits | New |
30/04/2024 | Referral: Mysimba - referral | Updated |
30/04/2024 | Medicine: Hexacima | Updated |
30/04/2024 | Medicine: Bimzelx | Updated |
30/04/2024 | Medicine: Lenvima | Updated |
30/04/2024 | Medicine: Kisplyx | Updated |
30/04/2024 | Document: Guidebook for tenderers | Updated |
30/04/2024 | Medicine: Bydureon | Updated |
30/04/2024 | Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) | Updated |
30/04/2024 | Event: Simultaneous National Scientific Advice - information and training webinar | Updated |
30/04/2024 | Page: Clinical Trials Information System: training and support | Updated |
30/04/2024 | News: ETF recommends updating COVID-19 vaccines to target new JN.1 variant | New |
30/04/2024 | Medicine: Lyumjev (previously Liumjev) | Updated |
30/04/2024 | Page: Public-health advice on COVID-19 medicines | Updated |
30/04/2024 | Post-authorisation: Orencia - withdrawal of application for variation to marketing authorisation | Updated |
30/04/2024 | Page: Epidemiological data on blood transmissible infections - Scientific guideline | Updated |
30/04/2024 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
29/04/2024 | Medicine: Nuvaxovid | Updated |
29/04/2024 | Document: Minutes of the CAT meeting 13-15 March 2024 | New |
29/04/2024 | Document: Creon (pancrelipase/pancreas powder) supply shortage | New |
29/04/2024 | Event: Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | New |
29/04/2024 | Page: ICH Q3C (R9) Residual solvents - Scientific guideline | Updated |
29/04/2024 | Medicine: Hexyon | Updated |
29/04/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 22 March 2024 | New |
29/04/2024 | Referral: Ocaliva - referral | Updated |
29/04/2024 | Medicine: Sunlenca | Updated |
29/04/2024 | Medicine: Hemlibra | Updated |
29/04/2024 | Medicine: Carvykti | Updated |
29/04/2024 | Medicine: Xgeva | Updated |
29/04/2024 | News: EMA closed 1 May | New |
29/04/2024 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
29/04/2024 | Event: Enpr-EMA Coordinating Group meeting March 2024 | New |
29/04/2024 | Event: Committee for Advanced Therapies (CAT): 13-15 March 2024 | Updated |
26/04/2024 | Medicine: Prevenar 20 (previously Apexxnar) | Updated |
26/04/2024 | Medicine: Xevudy | Updated |
26/04/2024 | Document: Organisation chart of the European Medicines Agency | Updated |
26/04/2024 | Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers | Updated |
26/04/2024 | Page: Development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations | New |
26/04/2024 | Page: Scientific guidelines for veterinary medicines | Updated |
26/04/2024 | Document: Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations | New |
26/04/2024 | News: Confidentiality arrangement between the EU and the Republic of Korea | New |
26/04/2024 | Document: Working arrangement between the Ministry of Food and Drug Safety of the Republic of Korea and the Directorate-General for Health and Food Safety of the European Commission and EMA for the Exchange of Non-Public Information on Medicinal Products | New |
26/04/2024 | Document: Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6) | Updated |
26/04/2024 | Document: QRD Form 2 and checklist for the submission of day +25 files - veterinary | Updated |
26/04/2024 | Post-authorisation: Alecensa - opinion on variation to marketing authorisation | New |
26/04/2024 | Post-authorisation: Reyataz - opinion on variation to marketing authorisation | New |
26/04/2024 | Post-authorisation: Triumeq - opinion on variation to marketing authorisation | New |
26/04/2024 | Post-authorisation: Sirturo - opinion on variation to marketing authorisation | New |
26/04/2024 | Post-authorisation: Rybrevant - opinion on variation to marketing authorisation | New |
26/04/2024 | Medicine: Truqap | New |
26/04/2024 | Post-authorisation: Rozlytrek - opinion on variation to marketing authorisation | New |
26/04/2024 | Post-authorisation: Opdivo - opinion on variation to marketing authorisation | New |
26/04/2024 | Medicine: Wezenla | New |
26/04/2024 | Medicine: GeGant | New |
26/04/2024 | Medicine: Eribulin Baxter | New |
26/04/2024 | Medicine: Altuvoct | New |
26/04/2024 | Medicine: Obgemsa | New |
26/04/2024 | Medicine: Jeraygo | New |
26/04/2024 | Page: SME Regulation and reports | Updated |
26/04/2024 | Document: Small and medium-sized enterprise (SME) office annual report 2023 | New |
26/04/2024 | Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | New |
26/04/2024 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
26/04/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024 | Updated |
26/04/2024 | Document: Minutes of the CVMP meeting 12-13 March 2024 | New |
25/04/2024 | Medicine: Xtandi | Updated |
25/04/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 April 2024 | Updated |
25/04/2024 | Medicine: Innovax-ND-H5 | New |
25/04/2024 | Document: List of centrally authorised products requiring a notification of a change for update of annexes | Updated |
25/04/2024 | Page: Non-clinical Working Party | Updated |
25/04/2024 | Document: Guide on access to unpublished documents | Updated |
25/04/2024 | Event: SPOR Status Update | Updated |
25/04/2024 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies | New |
25/04/2024 | Event: Joint HMA/EMA Big Data Steering Group workshop on RWE methods | Updated |
25/04/2024 | PSUSA: PSUSA/00002068/202308 - periodic safety update report single assessment | New |
25/04/2024 | Medicine: Sifrol | Updated |
25/04/2024 | Medicine: Quviviq | Updated |
25/04/2024 | Medicine: Nepexto | Updated |
25/04/2024 | Medicine: Bimervax | Updated |
24/04/2024 | Medicine: Tecartus | Updated |
24/04/2024 | Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) | Updated |
24/04/2024 | Medicine: Spedra | Updated |
24/04/2024 | Document: Agenda - Fourth EMA-AESGP bilateral meeting | New |
24/04/2024 | Event: Fifth European Medicines Agency (EMA) and the Association of the European Self-Medication Industry (AESGP) bilateral meeting | New |
24/04/2024 | Document: Minimum inhibitory concentration (MIC) breakpoints | Updated |
24/04/2024 | Event: Psychedelics and their therapeutic use - Linkedin Live interview with Steffen Thirstrup, EMA's Chief Medical Officer | New |
24/04/2024 | Medicine: Fruzaqla | New |
23/04/2024 | Page: Training and resources for patients and consumers | Updated |
23/04/2024 | Page: Republic of Korea | New |
23/04/2024 | Medicine: Pramipexole Teva | Updated |
23/04/2024 | Medicine: Ontozry | Updated |
23/04/2024 | Medicine: Emend | Updated |
23/04/2024 | Document: Emend (aprepitant) supply shortage | Updated |
23/04/2024 | Medicine: Kaftrio | Updated |
23/04/2024 | Medicine: Sitagliptin / Metformin hydrochloride Accord | Updated |
23/04/2024 | Medicine: Revatio | Updated |
23/04/2024 | Medicine: Oyavas | Updated |
23/04/2024 | News: New recommendations to strengthen supply chains of critical medicines | New |
23/04/2024 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products | Updated |
23/04/2024 | Document: MSSG recommendations to strengthen supply chains of critical medicinal products | New |
23/04/2024 | Medicine: Hukyndra | Updated |
23/04/2024 | Document: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products | Updated |
23/04/2024 | Document: Member states contact points for review of national versions of the content of mobile scanning and other technologies | Updated |
23/04/2024 | Document: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages | Updated |
23/04/2024 | Document: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group | Updated |
23/04/2024 | Event: Paediatric Committee (PDCO): 23-26 April 2024 | Updated |
23/04/2024 | Document: Agenda - PDCO agenda of the 23-26 April 2024 meeting | New |
23/04/2024 | Document: Agenda of the CHMP meeting 22-25 April 2024 | Updated |
22/04/2024 | Medicine: Lunsumio | Updated |
22/04/2024 | PSUSA: PSUSA/00010425/202308 - periodic safety update report single assessment | New |
22/04/2024 | PSUSA: PSUSA/00010163/202308 - periodic safety update report single assessment | New |
22/04/2024 | Document: List of medicinal products under additional monitoring | Updated |
22/04/2024 | Document: List of medicinal products under additional monitoring | Updated |
22/04/2024 | Medicine: Lorviqua | Updated |
22/04/2024 | Medicine: Tofidence | New |
22/04/2024 | Page: List of medicines under additional monitoring | Updated |
22/04/2024 | Medicine: Jentadueto | Updated |
22/04/2024 | Medicine: Posaconazole AHCL | Updated |
22/04/2024 | Medicine: Posaconazole Accord | Updated |
22/04/2024 | Medicine: Lemtrada | Updated |
22/04/2024 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings | Updated |
22/04/2024 | Event: Clinical Trials Information System (CTIS) Bitesize Talk: How to submit a transitional trial in CTIS | Updated |
22/04/2024 | Medicine: Granupas (previously Para-aminosalicylic acid Lucane) | Updated |
22/04/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024 | Updated |
22/04/2024 | Medicine: Nintedanib Accord | Updated |
19/04/2024 | Medicine: Lymphoseek | Updated |
19/04/2024 | Event: Paediatric Oncology Strategy Forum: 24-25 October 2024 | New |
19/04/2024 | Medicine: Cyramza | Updated |
19/04/2024 | Event: Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS | New |
19/04/2024 | Event: Network Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS | New |
19/04/2024 | Medicine: Respivac TRT | New |
19/04/2024 | Document: Call for proposals - Grant procedure EMA/GRANT/2024/02/IA “Medicines regulatory systems strengthening in Sub-Saharan Africa” | New |
19/04/2024 | Document: Annex II to the call for proposals - Vendor financial identification form | New |
19/04/2024 | Document: Annex Va to the call for proposals - Draft grant agreement for an action with one beneficiary | New |
19/04/2024 | Document: Annex Vb to the call for proposals - Draft grant agreement for an action with multiple beneficiaries | New |
19/04/2024 | Event: Product Management Service (PMS) Product UI and API training (access & navigation) | New |
19/04/2024 | Event: EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework | Updated |
19/04/2024 | Event: Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024 | Updated |
19/04/2024 | Medicine: Abiraterone Accord | Updated |
19/04/2024 | Event: SPOR Status Update | New |
19/04/2024 | Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) | Updated |
19/04/2024 | Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMP | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measure (PAM) assessed by CHMP | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measure (PAM) assessed by PRAC | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP | Updated |
19/04/2024 | Document: Timetable: Post-authorisation measure (PAM) assessed by CAT | Updated |
19/04/2024 | Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables | Updated |
19/04/2024 | Document: Timetable: Informed consent and multiple application | Updated |
19/04/2024 | Document: Timetable: Initial (full) marketing authorisation application assessment | Updated |
19/04/2024 | PSUSA: PSUSA/00010752/202308 - periodic safety update report single assessment | New |
18/04/2024 | Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP) | Updated |
18/04/2024 | Document: Timetable: Extension application | Updated |
18/04/2024 | Document: Timetable accelerated assessment request for initial marketing authorisation applications | Updated |
18/04/2024 | Document: Timetable: Extension application - ATMP | Updated |
18/04/2024 | Medicine: Sitagliptin / Metformin hydrochloride Mylan | Updated |
18/04/2024 | Document: Timetable: Companion diagnostic initial consultation - ATMP | Updated |
18/04/2024 | Medicine: Inflectra | Updated |
18/04/2024 | Medicine: Cystagon | Updated |
18/04/2024 | Medicine: Ponvory | Updated |
18/04/2024 | Medicine: Ayvakyt | Updated |
18/04/2024 | Medicine: Alymsys | Updated |
18/04/2024 | Medicine: Javlor | Updated |
18/04/2024 | Document: Timetable: Accelerated assessment request for initial marketing authorisations - ATMP | Updated |
18/04/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2024 | Updated |
18/04/2024 | Page: European Shortages Monitoring Platform | New |
18/04/2024 | Medicine: Betmiga | Updated |
18/04/2024 | Document: Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6 | New |
18/04/2024 | Document: Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1 | New |
18/04/2024 | Medicine: Zinplava | Updated |
18/04/2024 | Medicine: Kinzalkomb | Updated |
18/04/2024 | Medicine: Dabigatran Etexilate Leon Farma | Updated |
18/04/2024 | Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP) | Updated |
18/04/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2024 | Updated |
18/04/2024 | Medicine: Takhzyro | Updated |
17/04/2024 | Document: Medicinal products for human use: monthly figures - March 2024 | New |
17/04/2024 | Document: Timetable: Companion diagnostic follow-up consultation | Updated |
17/04/2024 | Document: Timetable: Companion diagnostic follow-up consultation - ATMP | Updated |
17/04/2024 | Document: Timetable: Companion diagnostic initial consultation | Updated |
17/04/2024 | Medicine: Xolair | Updated |
17/04/2024 | PSUSA: PSUSA/00010444/202309 - periodic safety update report single assessment | New |
17/04/2024 | PSUSA: PSUSA/00009201/202308 - periodic safety update report single assessment | New |
17/04/2024 | PIP: EMEA-002981-PIP01-21 - paediatric investigation plan | Updated |
17/04/2024 | Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animals | Updated |
17/04/2024 | Medicine: Tepkinly | Updated |
17/04/2024 | Medicine: Ocaliva | Updated |
17/04/2024 | Medicine: Orserdu | Updated |
17/04/2024 | Medicine: Venclyxto | Updated |
17/04/2024 | News: COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements | New |
17/04/2024 | Page: International Coalition of Medicines Regulatory Authorities (ICMRA) | Updated |
16/04/2024 | Medicine: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) | Updated |
16/04/2024 | Medicine: Briviact (in Italy: Nubriveo) | Updated |
16/04/2024 | Page: Paediatric investigation plans: submitting documents | Updated |
16/04/2024 | Medicine: Entyvio | Updated |
16/04/2024 | Medicine: Evrenzo | Updated |
16/04/2024 | Medicine: Veoza | Updated |
16/04/2024 | Event: EMA traineeship programme informative session | New |
16/04/2024 | Medicine: Zoonotic Influenza Vaccine Seqirus | Updated |
16/04/2024 | Event: Clinical Trials Information System Webinar: Last Year of Transition | Updated |
16/04/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 26 February 2024 | Updated |
16/04/2024 | Event: ACT EU Clinical Trials Analytics Workshop - January 2024 | Updated |
16/04/2024 | Event: Committee for Orphan Medicinal Products (COMP): 16-18 April 2024 | Updated |
15/04/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, cover letter | Updated |
15/04/2024 | PSUSA: PSUSA/00010224/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00010242/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00003151/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00000435/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00002322/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00002392/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00003012/202308 - periodic safety update report single assessment | New |
15/04/2024 | Medicine: Translarna | Updated |
15/04/2024 | PSUSA: PSUSA/00002834/202308 - periodic safety update report single assessment | New |
15/04/2024 | PSUSA: PSUSA/00000986/202309 - periodic safety update report single assessment | New |
15/04/2024 | Medicine: Scemblix | Updated |
15/04/2024 | Medicine: Jakavi | Updated |
15/04/2024 | Medicine: Vargatef | Updated |
15/04/2024 | Medicine: Xospata | Updated |
15/04/2024 | Medicine: Holoclar | Updated |
15/04/2024 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
15/04/2024 | Herbal: Pilosellae herba cum radice - herbal medicinal product | Updated |
15/04/2024 | Herbal: Eucalypti aetheroleum - herbal medicinal product | Updated |
15/04/2024 | Page: Template for a European Union herbal monograph | Updated |
15/04/2024 | Document: Template for a European Union herbal monograph | New |
12/04/2024 | Event: Committee for Advanced Therapies (CAT) meeting with interested parties, May 2023 | New |
12/04/2024 | Medicine: Darzalex | Updated |
12/04/2024 | Medicine: Zeposia | Updated |
12/04/2024 | Event: Cancer Medicines Forum: February 2024 | New |
12/04/2024 | Document: Guidance on real-world evidence provided by EMA: support for regulatory decision-making | New |
12/04/2024 | Document: Minutes of the 122nd meeting of the Management Board, 13-14 December 2023 | New |
12/04/2024 | PSUSA: PSUSA/00002506/202308 - periodic safety update report single assessment | New |
12/04/2024 | PSUSA: PSUSA/00000858/202307 - periodic safety update report single assessment | New |
12/04/2024 | PSUSA: PSUSA/00001850/202307 - periodic safety update report single assessment | New |
12/04/2024 | PSUSA: PSUSA/00001040/202307 - periodic safety update report single assessment | New |
12/04/2024 | PSUSA: PSUSA/00003134/202305 - periodic safety update report single assessment | New |
12/04/2024 | Medicine: Eladynos | Updated |
12/04/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024 | New |
12/04/2024 | PSUSA: PSUSA/00002411/202303 - periodic safety update report single assessment | New |
12/04/2024 | PSUSA: PSUSA/00010178/202308 - periodic safety update report single assessment | New |
12/04/2024 | Page: Pharmaceutical quality of inhalation and nasal products - Scientific guideline | Updated |
12/04/2024 | Document: Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products | New |
12/04/2024 | Document: Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier | New |
12/04/2024 | Document: Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) | New |
11/04/2024 | PIP: EMEA-000727-PIP01-09-M07 - paediatric investigation plan | Updated |
11/04/2024 | Medicine: Wegovy | Updated |
11/04/2024 | Medicine: Rybelsus | Updated |
11/04/2024 | Medicine: Ozempic | Updated |
11/04/2024 | PSUSA: PSUSA/00001392/202308 - periodic safety update report single assessment | New |
11/04/2024 | Orphan: EU/3/16/1714 - orphan designation for treatment of mucopolysaccharidosis type I | Updated |
11/04/2024 | Orphan: EU/3/14/1236 - orphan designation for treatment of epidermolysis bullosa | Updated |
11/04/2024 | Document: Membership list: HMA-EMA joint Big Data Steering Group | Updated |
11/04/2024 | Orphan: EU/3/23/2873 - orphan designation for treatment of tenosynovial giant cell tumour, localised and diffuse type | Updated |
11/04/2024 | Orphan: EU/3/17/1861 - orphan designation for treatment of pulmonary arterial hypertension | Updated |
11/04/2024 | Orphan: EU/3/22/2723 - orphan designation for treatment of ovarian cancer | Updated |
11/04/2024 | Orphan: EU/3/20/2265 - orphan designation for treatment of acute myeloid leukaemia | Updated |
11/04/2024 | Orphan: EU/3/15/1515 - orphan designation for treatment of cutaneous T-cell lymphoma | Updated |
11/04/2024 | Orphan: EU/3/19/2184 - orphan designation for treatment of neurofibromatosis type 1 | Updated |
11/04/2024 | Orphan: EU/3/05/317 - orphan designation for treatment of graft-versus-host disease | Updated |
11/04/2024 | Medicine: Yorvipath | Updated |
11/04/2024 | Orphan: EU/3/10/756 - orphan designation for prevention of scarring post glaucoma filtration surgery | Updated |
11/04/2024 | Orphan: EU/3/20/2311 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes | Updated |
11/04/2024 | Orphan: EU/3/20/2319 - orphan designation for treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency | Updated |
11/04/2024 | Orphan: EU/3/18/2010 - orphan designation for treatment of spinal muscular atrophy | Updated |
11/04/2024 | Event: Focus group on veterinary pharmacovigilance reporting in aquaculture | Updated |
11/04/2024 | Medicine: Myclausen | Updated |
11/04/2024 | Orphan: EU/3/17/1938 - orphan designation for treatment of epidermolysis bullosa | Updated |
11/04/2024 | Orphan: EU/3/18/2080 - orphan designation for treatment of haemophilia B | Updated |
11/04/2024 | Medicine: Febuxostat Viatris (previously Febuxostat Mylan) | Updated |
11/04/2024 | Orphan: EU/3/24/2897 - orphan designation for treatment of focal segmental glomerulosclerosis | New |
11/04/2024 | Medicine: Lacosamide UCB | Updated |
11/04/2024 | Orphan: EU/3/24/2901 - orphan designation for treatment of fibrodysplasia ossificans progressiva | New |
11/04/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - March 2024 | Updated |
11/04/2024 | Orphan: EU/3/24/2890 - orphan designation for treatment of ovarian cancer | New |
11/04/2024 | Orphan: EU/3/24/2892 - orphan designation for treatment of small cell lung cancer | New |
11/04/2024 | Medicine: CellCept | Updated |
11/04/2024 | Orphan: EU/3/24/2891 - orphan designation for treatment of glioma | New |
11/04/2024 | Orphan: EU/3/24/2899 - orphan designation for treatment of acute respiratory distress syndrome (ARDS) | New |
11/04/2024 | Medicine: Padcev | Updated |
11/04/2024 | Orphan: EU/3/24/2898 - orphan designation for treatment of hereditary angioedema | New |
11/04/2024 | Orphan: EU/3/24/2900 - orphan designation for treatment of AL amyloidosis | New |
11/04/2024 | Orphan: EU/3/24/2896 - orphan designation for treatment of ATTR amyloidosis | New |
11/04/2024 | Event: Eighth Industry Standing Group (ISG) meeting | Updated |
11/04/2024 | Orphan: EU/3/23/2887 - orphan designation for treatment of recurrent respiratory papillomatosis | New |
11/04/2024 | Orphan: EU/3/23/2888 - orphan designation for treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) | New |
11/04/2024 | Orphan: EU/3/23/2881 - orphan designation for treatment of acute myeloid leukaemia | New |
11/04/2024 | Orphan: EU/3/23/2877 - orphan designation for treatment of amyotrophic lateral sclerosis | New |
11/04/2024 | Orphan: EU/3/23/2884 - orphan designation for treatment of Rett syndrome | New |
11/04/2024 | Orphan: EU/3/23/2883 - orphan designation for alpha-thalassaemia X-linked intellectual disability syndrome (due to mutations in the ATRX gene) | New |
11/04/2024 | Orphan: EU/3/23/2876 - orphan designation for treatment of small cell lung cancer | New |
11/04/2024 | Medicine: Glivec | Updated |
11/04/2024 | Medicine: Fampridine Accord | Updated |
11/04/2024 | Medicine: Xromi | Updated |
11/04/2024 | Medicine: Entecavir Viatris (previously Entecavir Mylan) | Updated |
11/04/2024 | Orphan: EU/3/23/2885 - orphan designation for treatment of patients undergoing haematopoietic stem cell transplantation | New |
11/04/2024 | Orphan: EU/3/23/2889 - orphan designation for treatment of thalassaemia intermedia and major | New |
11/04/2024 | Orphan: EU/3/23/2875 - orphan designation for diagnosis of glioma | New |
11/04/2024 | Orphan: EU/3/23/2879 - orphan designation for treatment of insulinoma | New |
11/04/2024 | Orphan: EU/3/23/2882 - orphan designation for treatment of eosinophilic granulomatosis with polyangiitis | New |
11/04/2024 | Orphan: EU/3/23/2878 - orphan designation for treatment of diffuse large B-cell lymphoma | New |
11/04/2024 | Orphan: EU/3/23/2886 - orphan designation for treatment of acquired factor X deficiency | New |
11/04/2024 | Orphan: EU/3/23/2874 - orphan designation for treatment of systemic sclerosis | New |
11/04/2024 | Orphan: EU/3/24/2894 - orphan designation for treatment of cystic fibrosis | New |
11/04/2024 | Event: Cancer Medicines Forum workshop: April 2024 | Updated |
11/04/2024 | Medicine: Gardasil 9 | Updated |
11/04/2024 | Medicine: Zaltrap | Updated |
11/04/2024 | Medicine: Ambrisentan Mylan | Updated |
11/04/2024 | Medicine: Tessie | Updated |
11/04/2024 | Page: Scientific publications | Updated |
10/04/2024 | Medicine: Myfenax | Updated |
10/04/2024 | Medicine: Mycophenolate mofetil Teva | Updated |
10/04/2024 | Medicine: Ranexa (previously Latixa) | Updated |
10/04/2024 | Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) | Updated |
10/04/2024 | Medicine: Cancidas (previously Caspofungin MSD) | Updated |
10/04/2024 | Medicine: Gavreto | Updated |
10/04/2024 | Medicine: Nivestim | Updated |
10/04/2024 | Medicine: Abilify Maintena | Updated |
10/04/2024 | Medicine: Sarclisa | Updated |
10/04/2024 | Medicine: Kyprolis | Updated |
10/04/2024 | Medicine: Aerinaze | Updated |
09/04/2024 | Medicine: Ninlaro | Updated |
09/04/2024 | Medicine: Tepadina | Updated |
09/04/2024 | Medicine: Dupixent | Updated |
09/04/2024 | Event: Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS | Updated |
09/04/2024 | Page: Variations not requiring assessment (veterinary medicines) | Updated |
09/04/2024 | Event: Focus group on veterinary pharmacovigilance reporting in poultry | Updated |
09/04/2024 | Orphan: EU/3/18/2090 - orphan designation for treatment of haemophilia B | Updated |
09/04/2024 | Orphan: EU/3/10/830 - orphan designation for treatment of ovarian cancer | Updated |
09/04/2024 | Orphan: EU/3/14/1265 - orphan designation for treatment of ovarian cancer | Updated |
09/04/2024 | Orphan: EU/3/11/902 - orphan designation for treatment of neuroblastoma | Updated |
09/04/2024 | Orphan: EU/3/16/1808 - orphan designation for treatment of systemic sclerosis | Updated |
09/04/2024 | Orphan: EU/3/20/2334 - orphan designation for treatment of aspartylglucosaminuria | Updated |
09/04/2024 | Orphan: EU/3/16/1736 - orphan designation for treatment of cystic fibrosis | Updated |
09/04/2024 | Orphan: EU/3/18/2070 - orphan designation for treatment of dermatomyositis | Updated |
09/04/2024 | Orphan: EU/3/20/2324 - orphan designation for treatment of von Hippel-Lindau disease | Updated |
09/04/2024 | Orphan: EU/3/20/2309 - orphan designation for treatment of idiopathic pulmonary fibrosis | Updated |
09/04/2024 | Orphan: EU/3/09/632 - orphan designation for treatment of acute intermittent porphyria | Updated |
09/04/2024 | Orphan: EU/3/12/974 - orphan designation for treatment of primary hyperoxaluria type 1 | Updated |
09/04/2024 | Orphan: EU/3/09/663 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
09/04/2024 | Orphan: EU/3/16/1631 - orphan designation for diagnosis of glioma | Updated |
09/04/2024 | Orphan: EU/3/16/1632 - orphan designation for diagnosis of hepatocellular carcinoma | Updated |
09/04/2024 | Orphan: EU/3/22/2593 - orphan designation for treatment of phenylalanine hydroxylase deficiency | Updated |
09/04/2024 | Orphan: EU/3/20/2341 - orphan designation for treatment of Fabry disease | Updated |
09/04/2024 | Orphan: EU/3/18/2015 - orphan designation for treatment of haemophilia A | Updated |
09/04/2024 | Orphan: EU/3/20/2326 - orphan designation for treatment of Gaucher disease | Updated |
09/04/2024 | Medicine: Komboglyze | Updated |
09/04/2024 | Medicine: Myozyme | Updated |
09/04/2024 | Medicine: Braftovi | Updated |
09/04/2024 | Document: Minutes of the PRAC meeting 5-8 February 2024 | New |
08/04/2024 | Medicine: Bondronat | Updated |
08/04/2024 | Medicine: Bonviva | Updated |
08/04/2024 | Medicine: Xydalba | Updated |
08/04/2024 | Orphan: EU/3/19/2135 - orphan designation for treatment of DiGeorge syndrome | Updated |
08/04/2024 | Orphan: EU/3/19/2136 - orphan designation for treatment of CHARGE syndrome | Updated |
08/04/2024 | Orphan: EU/3/21/2568 - orphan designation for prevention of bronchopulmonary dysplasia | Updated |
08/04/2024 | Orphan: EU/3/19/2183 - orphan designation for treatment of WHIM syndrome | Updated |
08/04/2024 | Document: Agenda of the PRAC meeting 8-11 April 2024 | New |
08/04/2024 | Orphan: EU/3/20/2271 - orphan designation for treatment in haematopoietic stem cell transplantation | Updated |
08/04/2024 | Orphan: EU/3/15/1534 - orphan designation for treatment of Rett syndrome | Updated |
08/04/2024 | Orphan: EU/3/15/1529 - orphan designation for treatment of fragile X syndrome | Updated |
08/04/2024 | Orphan: EU/3/19/2203 - orphan designation for treatment of Netherton syndrome | Updated |
08/04/2024 | Orphan: EU/3/19/2214 - orphan designation for treatment of soft tissue sarcoma | Updated |
08/04/2024 | Orphan: EU/3/21/2511 - orphan designation for treatment of Krabbe disease | Updated |
08/04/2024 | Orphan: EU/3/16/1759 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
08/04/2024 | Orphan: EU/3/21/2563 - orphan designation for treatment of invasive Scopulariopsis | Updated |
08/04/2024 | Orphan: EU/3/12/978 - orphan designation for treatment of perinatal asphyxia | Updated |
08/04/2024 | Orphan: EU/3/21/2407 - orphan designation for treatment of cystinosis | Updated |
08/04/2024 | Orphan: EU/3/21/2449 - orphan designation for treatment of pulmonary arterial hypertension | Updated |
08/04/2024 | Orphan: EU/3/07/434 - orphan designation for treatment of Leber's hereditary optic neuropathy | Updated |
08/04/2024 | Orphan: EU/3/20/2354 - orphan designation for treatment of microvillus inclusion disease | Updated |
08/04/2024 | Orphan: EU/3/22/2606 - orphan designation for treatment of haemophilia A | Updated |
08/04/2024 | Orphan: EU/3/19/2232 - orphan designation for treatment of amyotrophic lateral sclerosis | Updated |
08/04/2024 | Orphan: EU/3/22/2715 - orphan designation for treatment of spinocerebellar ataxia | Updated |
08/04/2024 | Medicine: Viagra | Updated |
08/04/2024 | Page: Contacts at the European Medicines Agency | Updated |
08/04/2024 | Page: Services and databases | Updated |
08/04/2024 | Medicine: Enjaymo | Updated |
08/04/2024 | News: EMA systems disruption expected from 11 to 17 April | New |
08/04/2024 | PIP: EMEA-001821-PIP01-15-M06 - paediatric investigation plan | Updated |
08/04/2024 | PIP: EMEA-002063-PIP01-16-M02 - paediatric investigation plan | Updated |
08/04/2024 | PIP: EMEA-002070-PIP01-16-M07 - paediatric investigation plan | Updated |
08/04/2024 | PIP: EMEA-002079-PIP01-16-M03 - paediatric investigation plan | Updated |
08/04/2024 | PIP: EMEA-003170-PIP01-21-M01 - paediatric investigation plan | Updated |
08/04/2024 | Medicine: Cibinqo | Updated |
05/04/2024 | PIP: EMEA-000334-PIP01-08-M11 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-000576-PIP01-09-M14 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-000997-PIP01-10-M06 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001220-PIP01-11-M07 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-003238-PIP01-22 - paediatric investigation plan | New |
05/04/2024 | PIP: EMEA-003241-PIP01-22 - paediatric investigation plan | New |
05/04/2024 | PIP: EMEA-003245-PIP01-22 - paediatric investigation plan | New |
05/04/2024 | Medicine: Imfinzi | Updated |
05/04/2024 | PIP: EMEA-003317-PIP02-22 - paediatric investigation plan | New |
05/04/2024 | Medicine: Aspaveli | Updated |
05/04/2024 | Medicine: Strimvelis | Updated |
05/04/2024 | PIP: EMEA-003032-PIP01-21-M01 - paediatric investigation plan | Updated |
05/04/2024 | Medicine: Lonsurf | Updated |
05/04/2024 | Medicine: Perjeta | Updated |
05/04/2024 | PIP: EMEA-001809-PIP01-15-M03 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001744-PIP01-14-M02 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001734-PIP01-14-M06 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001332-PIP01-12-M06 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001429-PIP01-13-M07 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-003237-PIP01-22 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-003218-PIP01-22 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-003171-PIP01-21 - paediatric investigation plan | Updated |
05/04/2024 | PIP: EMEA-001371-PIP03-22 - paediatric investigation plan | New |
05/04/2024 | PIP: P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22) - paediatric investigation plan | New |
05/04/2024 | Document: Traineeship - Frequently asked questions (FAQs) | Updated |
05/04/2024 | PIP: EMEA-002690-PIP02-22 - paediatric investigation plan | New |
05/04/2024 | PIP: EMEA-003166-PIP01-21 - paediatric investigation plan | New |
05/04/2024 | PIP: EMEA-003215-PIP01-22 - paediatric investigation plan | New |
05/04/2024 | Medicine: Instanyl | Updated |
04/04/2024 | Page: Transfer of marketing authorisation: questions and answers | Updated |
04/04/2024 | Document: List of industry subject matter experts and list of planned calls for industry subject matter experts | Updated |
04/04/2024 | PSUSA: PSUSA/00002307/202306 - periodic safety update report single assessment | New |
04/04/2024 | PSUSA: PSUSA/00001711/202307 - periodic safety update report single assessment | New |
04/04/2024 | Referral: Pseudoephedrine-containing medicinal products - referral | Updated |
04/04/2024 | Medicine: Niapelf | New |
04/04/2024 | Medicine: Opdivo | Updated |
04/04/2024 | Medicine: Prevenar 13 | Updated |
04/04/2024 | Medicine: Abiraterone Mylan | Updated |
04/04/2024 | Event: Paediatric Committee (PDCO): 20-23 February 2024 | Updated |
04/04/2024 | PSUSA: PSUSA/00002655/202306 - periodic safety update report single assessment | New |
04/04/2024 | PSUSA: PSUSA/00001713/202212 - periodic safety update report single assessment | New |
04/04/2024 | PSUSA: PSUSA/00001356/202212 - periodic safety update report single assessment | New |
04/04/2024 | PSUSA: PSUSA/00002664/202211 - periodic safety update report single assessment | New |
04/04/2024 | Medicine: PecFent | Updated |
04/04/2024 | Document: Day 80 assessment report - Clinical template with guidance - Rev.04.24 Revamp | Updated |
04/04/2024 | Medicine: Effentora | Updated |
04/04/2024 | Medicine: Dovato | Updated |
04/04/2024 | Medicine: Vfend | Updated |
04/04/2024 | Page: Assessment templates and guidance | Updated |
04/04/2024 | PSUSA: PSUSA/00003002/202306 - periodic safety update report single assessment | New |
04/04/2024 | Page: Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline | Updated |
03/04/2024 | Medicine: Rubraca | Updated |
03/04/2024 | Medicine: Sixmo | Updated |
03/04/2024 | Medicine: Ertapenem SUN | Updated |
03/04/2024 | Medicine: Bovilis Nasalgen-C | Updated |
03/04/2024 | Medicine: Sorafenib Accord | Updated |
03/04/2024 | Medicine: Levodopa/Carbidopa/Entacapone Orion | Updated |
03/04/2024 | Medicine: Revestive | Updated |
03/04/2024 | Medicine: Yuflyma | Updated |
03/04/2024 | Event: Committee for Orphan Medicinal Products (COMP): 13-15 February 2024 | Updated |
03/04/2024 | PSUSA: PSUSA/00002256/202307 - periodic safety update report single assessment | New |
03/04/2024 | Medicine: Abecma | Updated |
03/04/2024 | Page: Marketing authorisation templates | Updated |
02/04/2024 | Medicine: Celdoxome pegylated liposomal | Updated |
02/04/2024 | Medicine: Sutent | Updated |
02/04/2024 | Medicine: Pedmarqsi | Updated |
02/04/2024 | Medicine: Pylclari | Updated |
02/04/2024 | Page: Data protection and privacy | Updated |
02/04/2024 | Page: Medical devices | Updated |
02/04/2024 | Medicine: Locametz | Updated |
02/04/2024 | Medicine: Teriparatide Sun | Updated |
02/04/2024 | PSUSA: PSUSA/00002165/202306 - periodic safety update report single assessment | New |
02/04/2024 | Medicine: Cometriq | Updated |
02/04/2024 | Orphan: EU/3/08/610 - orphan designation for treatment of medullary thyroid carcinoma | Updated |
02/04/2024 | Herbal: Verbasci flos - herbal medicinal product | Updated |
02/04/2024 | Herbal: Vitis viniferae folium - herbal medicinal product | Updated |
02/04/2024 | Page: Procedures for monograph and list entry establishment | Updated |
02/04/2024 | Herbal: Oenotherae oleum - herbal medicinal product | Updated |
02/04/2024 | Herbal: Uvae ursi folium - herbal medicinal product | Updated |
02/04/2024 | Herbal: Melissae folium - herbal medicinal product | Updated |
02/04/2024 | Herbal: Myrrha - herbal medicinal product | Updated |
02/04/2024 | Herbal: Meliloti herba - herbal medicinal product | Updated |
02/04/2024 | Herbal: Cynarae folium - herbal medicinal product | Updated |
02/04/2024 | Herbal: Curcumae longae rhizoma - herbal medicinal product | Updated |
02/04/2024 | Medicine: Metalyse | Updated |