https://www.ema.europa.eu/en/homepageNews and press releasesen-gbCopyright: (C) European Medicines AgencyThu, 09 May 2024 05:45:08 +0200Tue, 07 May 2024 14:17:00 +0200https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.The CHMP recommended granting…, Positive recommendations on new medicines , AltuvoctInternational non-proprietary name (INN)efanesoctocog alfaMarketing-authorisation applicantSwedish Orphan Biovitrum AB (publ)Therapeutic indicationTreatment and…, FruzaqlaInternational non-proprietary name (INN)fruquintinibMarketing-authorisation applicantTakeda Pharmaceuticals International AG Ireland BranchTherapeutic indicationTreatment…, Jeraygo INNaprocitentanMarketing-authorisation applicantIdorsia Pharmaceuticals Deutschland GmbHTherapeutic indicationTreatment of resistant hypertension.More informationJeraygo:…, ObgemsaINNvibegronMarketing-authorisation applicantPierre Fabre MedicamentTherapeutic indicationTreatment of micturition frequency and/or urgency incontinence as may occur in…, TruqapINNcapivasertibMarketing-authorisation applicantAstraZeneca ABTherapeutic indicationIndicated in combination with fulvestrant for the treatment of adult patients with…, Positive recommendation on new biosimilar medicines , TofidenceINNtocilizumabMarketing-authorisation applicantBiogen Netherlands B.V.Therapeutic indicationTreatment of rheumatoid arthritis (RA), coronavirus disease 2019 (COVID-19),…, WezenlaINNustekinumabMarketing-authorisation applicantAmgen Technology (Ireland) Unlimited CompanyTherapeutic indicationTreatment of moderate to severe plaque psoriasis in adults…, Positive recommendation on new generic medicine , Eribulin BaxterINNeribulinMarketing-authorisation applicantBaxter Holding B.V.Therapeutic indicationTreatment of breast cancer and liposarcoma.More informationEribulin Baxter:…, Positive recommendations on extensions of indications , AlecensaINNalectinibMarketing-authorisation holderRoche Registration GmbHMore informationAlecensa: Pending EC decision, OpdivoINNnivolumabMarketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationOpdivo: Pending EC decision, RozlytrekINNentrectinibMarketing-authorisation holderRoche Registration GmbHMore informationRozlytrek: Pending EC decision, RybrevantINNamivantamabMarketing-authorisation holderJanssen-Cilag International N.V.More informationRybrevant: Pending EC decision, SirturoINNbedaquilineMarketing-authorisation holderJanssen-Cilag International N.V.More informationSirturo: Pending EC decision, TriumeqINNdolutegravir / abacavir / lamivudine Marketing-authorisation holderViiV Healthcare B.V.More informationTriumeq: Pending EC decision, Recommendation on new contraindication , ReyatazINNatazanavir sulfateMarketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationReyataz: Pending EC decision, Withdrawal of initial marketing authorisation application , GeGantINNgermanium (68Ge) chloride / gallium (68Ga) chlorideMarketing-authorisation applicantITM Medical Isotopes GmbHMore informationGeGant: Withdrawn applicationhttps://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024Tue, 07 May 2024 14:17:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/ema-closed-9-10-mayOutside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…https://www.ema.europa.eu/en/news/ema-closed-9-10-mayTue, 07 May 2024 14:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agenciesOne Health recognises the complex interplay between human, animal and plant health, food safety, the climate crisis and environmental sustainability. Implementing this approach…https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agenciesTue, 07 May 2024 12:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-april-2024CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective…https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-april-2024Tue, 30 Apr 2024 16:55:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variantEMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.JN.1 differs from the…https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variantTue, 30 Apr 2024 11:57:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/ema-closed-1-mayOutside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…https://www.ema.europa.eu/en/news/ema-closed-1-mayMon, 29 Apr 2024 13:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-republic-koreaThis new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal…https://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-republic-koreaFri, 26 Apr 2024 14:23:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicinesThese recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which…https://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicinesTue, 23 Apr 2024 13:31:26 +0200News and press releaseshttps://www.ema.europa.eu/en/news/covid-19-vaccine-strain-updates-global-regulators-agree-timing-data-requirementsInternational regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition…https://www.ema.europa.eu/en/news/covid-19-vaccine-strain-updates-global-regulators-agree-timing-data-requirementsWed, 17 Apr 2024 10:00:00 +0200News and press releaseshttps://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide,…, Agenda Agenda of the PRAC meeting 8-11 April 2024DraftReference Number: EMA/PRAC/97608/2024 English (EN…, PRAC statistics: April 2024 , PRAC statistics: April 2024 English (EN) (250.29 KB - PDF)First published: 12/04/2024View, Glossary: Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…, Ongoing referrals ProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessmenthttps://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024Fri, 12 Apr 2024 12:00:00 +0200News and press releases