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Find all new and updated information published on our website in one place below. Filters are available to narrow results down based on your interests, such as whether it relates to human or veterinary medicines or specific topics. This overview covers up to two months back. 

Results (246)


DateContentStatus
11/06/2025 Medicine: SkyriziUpdated
11/06/2025 PIP: EMEA-003390-PIP01-23 - paediatric investigation planNew
11/06/2025 Medicine: AbsimkyUpdated
11/06/2025 PIP: EMEA-003562-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003561-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003559-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003557-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003555-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003554-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003552-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003534-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003530-PIP01-23 - paediatric investigation planNew
11/06/2025 Event: 14th industry stakeholder platform on research and development supportNew
11/06/2025 Medicine: ZostavaxUpdated
11/06/2025 PIP: EMEA-003485-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003481-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003478-PIP01-23 - paediatric investigation planNew
11/06/2025 PIP: EMEA-003465-PIP01-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-002958-PIP01-21-M01 - paediatric investigation planUpdated
10/06/2025 PIP: EMEA-001585-PIP01-13-M06 - paediatric investigation planUpdated
10/06/2025 PIP: EMEA-002208-PIP01-17-M04 - paediatric investigation planUpdated
10/06/2025 PIP: EMEA-003071-PIP01-21-M01 - paediatric investigation planUpdated
10/06/2025 PIP: EMEA-003453-PIP01-23 - paediatric investigation planNew
10/06/2025 Medicine: ImuldosaUpdated
10/06/2025 PIP: EMEA-001198-PIP04-23 - paediatric investigation planNew
10/06/2025 PSUSA: PSUSA/00010988/202410 - periodic safety update report single assessmentNew
10/06/2025 PIP: EMEA-003439-PIP02-23 - paediatric investigation planNew
10/06/2025 Medicine: RozlytrekUpdated
10/06/2025 Medicine: RinvoqUpdated
10/06/2025 PIP: EMEA-002208-PIP02-24 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003543-PIP01-23 - paediatric investigation planNew
10/06/2025 Medicine: VokanametUpdated
10/06/2025 PIP: EMEA-003542-PIP01-23 - paediatric investigation planNew
10/06/2025 Medicine: CapvaxiveUpdated
10/06/2025 PIP: EMEA-003443-PIP02-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003551-PIP01-23 - paediatric investigation planNew
10/06/2025 Medicine: ZirabevUpdated
10/06/2025 Medicine: ApexelsinUpdated
10/06/2025 PIP: EMEA-003457-PIP01-23 - paediatric investigation planNew
10/06/2025 Document: Minutes of the COMP meeting 14-15 April 2025New
10/06/2025 Document: QRD Appendix V - Adverse-drug-reaction reporting detailsUpdated
10/06/2025 PIP: EMEA-003395-PIP02-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003454-PIP01-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003248-PIP02-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003434-PIP02-23 - paediatric investigation planNew
10/06/2025 PIP: EMEA-002883-PIP03-23 - paediatric investigation planNew
10/06/2025 Page: Annual reports and work programmesUpdated
10/06/2025 Document: Annexes - 2024 annual report of the European Medicines AgencyNew
10/06/2025 Document: Annex 10 - 2024 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indicationNew
10/06/2025 Document: 2024 annual report of the European Medicines AgencyNew
10/06/2025 Medicine: JyselecaUpdated
10/06/2025 PIP: EMEA-003393-PIP01-23 - paediatric investigation planNew
10/06/2025 News: 2024 annual report is published New
10/06/2025 PIP: EMEA-003333-PIP01-22 - paediatric investigation planNew
10/06/2025 PIP: EMEA-003299-PIP01-22 - paediatric investigation planNew
10/06/2025 Medicine: QoyvolmaUpdated
10/06/2025 PIP: EMEA-003277-PIP02-23 - paediatric investigation planNew
10/06/2025 Event: Training session on Human variations web-based electronic Application Form (eAF) for non-CAPsNew
10/06/2025 Document: Network Portfolio RoadmapUpdated
10/06/2025 Event: 1st EMA/HMA multi-stakeholder forum on EudraVigilance and signal detectionNew
10/06/2025 Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authoritiesUpdated
10/06/2025 Document: Quality control of medicinal product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No. 726/2004Updated
10/06/2025 Document: CHMP-CAT - D80-210 Overview to final EPAR - Rev 06.25 RevampUpdated
10/06/2025 Document: Day 80 assessment report - Non-clinical template with guidance - Rev 06.25 Revamp Updated
10/06/2025 Document: Agenda - Management Board meeting: 11-12 June 2025New
10/06/2025 Document: Agenda of the COMP meeting 10-12 June 2025New
10/06/2025 Document: Agenda of the CVMP meeting 10-12 June 2025New
10/06/2025 Orphan: EU/3/18/2012 - orphan designation for treatment of epidermolysis bullosaUpdated
10/06/2025 Orphan: EU/3/22/2736 - orphan designation for treatment of ornithine transcarbamylase deficiencyUpdated
10/06/2025 Orphan: EU/3/19/2140 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's syndrome)Updated
10/06/2025 Orphan: EU/3/20/2379 - orphan designation for treatment of Angelman syndromeUpdated
10/06/2025 Orphan: EU/3/21/2498 - orphan designation for treatment of frontotemporal dementiaUpdated
10/06/2025 Orphan: EU/3/17/1922 - orphan designation for treatment of acute myeloid leukaemiaUpdated
10/06/2025 Orphan: EU/3/21/2462 - orphan designation for treatment of propionic acidaemiaUpdated
10/06/2025 Orphan: EU/3/21/2461 - orphan designation for treatment of pantothenate kinase-associated neurodegenerationUpdated
10/06/2025 Orphan: EU/3/24/2931 - orphan designation for treatment of idiopathic pulmonary fibrosisUpdated
10/06/2025 Orphan: EU/3/21/2425 - orphan designation for treatment of cutaneous T-cell lymphomaUpdated
10/06/2025 Orphan: EU/3/20/2267 - orphan designation for treatment of progressive familial intrahepatic cholestasisUpdated
10/06/2025 Orphan: EU/3/25/3045 - orphan designation for prevention of fetal and neonatal alloimmune thrombocytopeniaNew
10/06/2025 Orphan: EU/3/25/3051 - orphan designation for treatment of familial adenomatous polyposis (FAP)New
10/06/2025 Orphan: EU/3/25/3052 - orphan designation for treatment of primary ubiquinone deficiencyNew
10/06/2025 Orphan: EU/3/25/3048 - orphan designation for treatment of primary IgA nephropathyNew
10/06/2025 Orphan: EU/3/25/3047 - orphan designation for treatment of Duchenne muscular dystrophyNew
06/06/2025 PIP: EMEA-002924-PIP02-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002727-PIP03-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002573-PIP02-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002490-PIP01-18 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002475-PIP04-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002341-PIP02-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002042-PIP03-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-001039-PIP04-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002861-PIP02-20-M07 - paediatric investigation planUpdated
06/06/2025 PIP: EMEA-002746-PIP01-20-M03 - paediatric investigation planUpdated
06/06/2025 PIP: EMEA-002736-PIP02-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-002618-PIP02-20-M01 - paediatric investigation planUpdated
06/06/2025 PIP: EMEA-003569-PIP01-23 - paediatric investigation planNew
06/06/2025 Medicine: BylvayUpdated
06/06/2025 PIP: EMEA-003405-PIP01-23 - paediatric investigation planNew
06/06/2025 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025New
06/06/2025 News: PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and WegovyNew
06/06/2025 PSUSA: PSUSA/00001842/202410 - periodic safety update report single assessmentNew
06/06/2025 Medicine: Epruvy (previously Ranibizumab Midas)Updated
06/06/2025 Medicine: RanivisioUpdated
06/06/2025 PIP: EMEA-003313-PIP03-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-003540-PIP01-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-003537-PIP01-23 - paediatric investigation planNew
06/06/2025 PIP: EMEA-003528-PIP01-23 - paediatric investigation planNew
06/06/2025 Medicine: EydenzeltUpdated
06/06/2025 Event: Quarterly System Demo - Q2 2025Updated
06/06/2025 PIP: EMEA-002016-PIP05-23 - paediatric investigation planNew
06/06/2025 Medicine: ZyprexaUpdated
06/06/2025 Medicine: HBVaxProUpdated
06/06/2025 Page: Executive Steering Group on Shortages and Safety of Medicinal ProductsUpdated
06/06/2025 Document: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) annual activity report 2024New
06/06/2025 Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data servicesUpdated
05/06/2025 PIP: EMEA-002600-PIP01-19-M02 - paediatric investigation planUpdated
05/06/2025 PIP: EMEA-002418-PIP01-18-M03 - paediatric investigation planUpdated
05/06/2025 PIP: EMEA-003220-PIP01-22-M01 - paediatric investigation planUpdated
05/06/2025 PIP: EMEA-003215-PIP01-22-M01 - paediatric investigation planUpdated
05/06/2025 Shortage: NovoSeven (eptacog alfa) Updated
05/06/2025 PSUSA: PSUSA/00000795/202410 - periodic safety update report single assessmentNew
05/06/2025 Document: Highlights - Second EMA / Alliance for Regenerative Medicine bilateral meetingNew
05/06/2025 Orphan: EU/3/04/211 - orphan designation for prevention of hepatic veno-occlusive diseaseUpdated
05/06/2025 Orphan: EU/3/13/1201 - orphan designation for prevention of graft-versus-host diseaseUpdated
05/06/2025 Orphan: EU/3/19/2224 - orphan designation for treatment of CDKL5 deficiency disorderUpdated
05/06/2025 Orphan: EU/3/21/2419 - orphan designation for treatment of ATTR amyloidosisUpdated
05/06/2025 Orphan: EU/3/22/2727 - orphan designation for diagnosis of neuroendocrine neoplasmsUpdated
05/06/2025 Orphan: EU/3/21/2503 - orphan designation for treatment of tuberous sclerosisUpdated
05/06/2025 Orphan: EU/3/11/930 - orphan designation for treatment of Hodgkin's lymphomaUpdated
05/06/2025 Orphan: EU/3/17/1928 - orphan designation for treatment of Leber's congenital amaurosisUpdated
05/06/2025 Orphan: EU/3/11/913 - orphan designation for treatment of hepatocellular carcinomaUpdated
05/06/2025 Orphan: EU/3/22/2664 - orphan designation for treatment of epidermolysis bullosaUpdated
05/06/2025 Orphan: EU/3/21/2560 - orphan designation for treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)Updated
05/06/2025 Orphan: EU/3/21/2405 - orphan designation for treatment of gastric cancerUpdated
05/06/2025 Orphan: EU/3/25/3050 - orphan designation for treatment of pre-eclampsiaNew
05/06/2025 Orphan: EU/3/25/3049 - orphan designation for treatment of spinal muscular atrophyNew
05/06/2025 Orphan: EU/3/25/3046 - orphan designation for treatment of non-infectious uveitisNew
05/06/2025 PSUSA: PSUSA/00000051/202410 - periodic safety update report single assessmentNew
05/06/2025 Event: EU Medicines Assessment - Opportunities for expert involvementNew
05/06/2025 News: EMA closed 9 JuneNew
05/06/2025 Medicine: Tigecycline AccordUpdated
05/06/2025 Event: EMA/FVE info session for veterinary practitioners : Understanding the first report of sales and use of antimicrobials in animalsUpdated
05/06/2025 Document: QRD veterinary product-information highlighted template version 9.1Updated
05/06/2025 Document: QRD veterinary product-information template version 9.1Updated
05/06/2025 Document: QRD veterinary combined label-leaflet template v.9.1Updated
05/06/2025 Document: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variationsUpdated
05/06/2025 Document: Minutes - PDCO minutes of the 22-25 April 2025 meetingNew
05/06/2025 Document: Minutes of the CHMP meeting 27-30 January 2025Updated
05/06/2025 Event: HMA/EMA multi-stakeholder workshop on artificial intelligenceNew
05/06/2025 Shortage: PegasysUpdated
05/06/2025 PIP: EMEA-003394-PIP01-23 - paediatric investigation planNew
05/06/2025 Medicine: EfmodyUpdated
05/06/2025 Medicine: ZtalmyUpdated
04/06/2025 Medicine: Pelgraz PaediatricUpdated
04/06/2025 PSUSA: PSUSA/00010855/202408 - periodic safety update report single assessmentNew
04/06/2025 Medicine: Rivaroxaban Viatris (previously Rivaroxaban Mylan)Updated
04/06/2025 Medicine: SpexotrasUpdated
04/06/2025 Medicine: FinleeUpdated
04/06/2025 Page: CHMP opinions on consultation proceduresUpdated
04/06/2025 Document: IVF Media G5 - Procedural steps and scientific information after initial consultationNew
04/06/2025 Document: IVF Media G5 - Procedural steps and scientific information after initial consultation (archive)Updated
04/06/2025 Medicine: Beqvez (previously Durveqtix)Updated
04/06/2025 Medicine: RoclandaUpdated
04/06/2025 Document: Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)Updated
04/06/2025 Page: Medicines during pregnancy and breastfeedingNew
04/06/2025 Medicine: TecvayliUpdated
04/06/2025 Document: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2Updated
04/06/2025 Event: Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 April 2025Updated
04/06/2025 Document: Minutes of the PRAC meeting 07-10 April 2025New
04/06/2025 Event: EMA roundtable with stakeholders on the 20th anniversary of the SME RegulationUpdated
04/06/2025 Medicine: RemicadeUpdated
04/06/2025 Event: Public webinar on shortages: putting patients firstNew
04/06/2025 Medicine: VekluryUpdated
04/06/2025 Document: Agenda - Workshop on the use of Bayesian statistics in clinical developmentUpdated
04/06/2025 Document: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trialsNew
04/06/2025 News: New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials New
03/06/2025 Medicine: IbranceUpdated
03/06/2025 Referral: Ixchiq - referralUpdated
03/06/2025 Page: Patients and consumersUpdated
03/06/2025 Medicine: Atropine sulfate FGKUpdated
03/06/2025 Medicine: MysimbaUpdated
03/06/2025 Referral: Mysimba - referralUpdated
03/06/2025 Document: Questions and answers on the refusal of the marketing authorisation for Atropine sulfate FGK (atropine sulfate)Updated
03/06/2025 Medicine: ZeffixUpdated
03/06/2025 Event: 13th Industry Standing Group (ISG) meetingNew
03/06/2025 Event: Clinical Trials Information System (CTIS): Information dayUpdated
03/06/2025 Page: Quality of medicines questions and answers: Part 2Updated
03/06/2025 Medicine: CholestagelUpdated
03/06/2025 Document: European Medicines Agency decision CW/0001/2025 of 2 June 2025 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the CouncilNew
03/06/2025 Page: Class waiversUpdated
03/06/2025 Document: EMA/PDCO summary report on the review of the list of granted Class Waivers 2 June 2025New
03/06/2025 Medicine: ImcivreeUpdated
03/06/2025 Document: Superseded - EMA/PDCO Summary Report on the review of the list of granted Class WaiversUpdated
03/06/2025 Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)Updated
03/06/2025 Page: World Health Organization (WHO)Updated
03/06/2025 Medicine: LeqembiUpdated
03/06/2025 Medicine: Atazanavir KrkaUpdated
02/06/2025 Medicine: Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)Updated
02/06/2025 Medicine: AbrysvoUpdated
02/06/2025 Medicine: TevimbraUpdated
02/06/2025 Medicine: TecartusUpdated
02/06/2025 Event: Pharmacovigilance Risk Assessment Committee (PRAC): 2 - 5 June 2025Updated
02/06/2025 Document: Faecal microbiota transplantation EU-IN Horizon Scanning ReportUpdated
02/06/2025 Document: Agenda of the PRAC meeting 2-5 June 2025New
02/06/2025 Event: Workshop on the use of Bayesian statistics in clinical developmentUpdated
02/06/2025 Document: CAT quarterly highlights and approved ATMPs - May 2025New
02/06/2025 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
02/06/2025 Page: Plasma master file certificatesUpdated
02/06/2025 Document: Organisation chart: Advisory functionsUpdated
02/06/2025 Document: Meeting summary - Medicine shortages (SPOC) working party 10-11 April 2025New
02/06/2025 Medicine: CamzyosUpdated
02/06/2025 Medicine: OpdivoUpdated
02/06/2025 Document: Applicant / marketing authorisation holder change of contact person for product invented name / product number templateUpdated
02/06/2025 Medicine: TakhzyroUpdated
02/06/2025 Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)Updated
02/06/2025 Medicine: XofluzaUpdated
02/06/2025 Page: PRIME: priority medicinesUpdated
02/06/2025 Document: List of medicines currently in PRIME schemeUpdated
02/06/2025 Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 May 2025New
02/06/2025 Medicine: UpstazaUpdated
02/06/2025 Medicine: WezenlaUpdated
02/06/2025 Page: Scientific and technical recommendations: Veterinary Medicines RegulationUpdated
02/06/2025 Medicine: HepizovacUpdated
02/06/2025 Medicine: PrazivetinUpdated
02/06/2025 Medicine: Prevestrus vetUpdated
02/06/2025 Medicine: Nobilis Multriva IBm+ND+EDSUpdated
02/06/2025 Medicine: Prasugrel Viatris (previously Prasugrel Mylan)Updated
02/06/2025 Medicine: Temozolomide AccordUpdated
02/06/2025 Medicine: RheumocamUpdated
02/06/2025 Event: Product Management Service (PMS) information day 2025Updated
02/06/2025 Page: PRAC recommendations on safety signalsUpdated
02/06/2025 Document: List of signals discussed at PRAC since September 2012Updated
02/06/2025 Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 May 2025 PRACNew
02/06/2025 Document: PRAC recommendations on signals adopted at the 5-8 May 2025 meetingNew
02/06/2025 Medicine: TrumenbaUpdated
02/06/2025 Page: Guidance documentsUpdated
02/06/2025 Document: Overview of comments received on 'Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations' (EMA/CVMP/55240/2025)New
02/06/2025 Document: Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variationsNew
02/06/2025 Page: Advisory functionsUpdated
02/06/2025 Herbal: Ononidis radix - herbal medicinal productUpdated
02/06/2025 Document: Draft European Union herbal monograph on Ononis spinosa L., radix - Revision 1New
02/06/2025 Medicine: VerzeniosUpdated
02/06/2025 PSUSA: PSUSA/00000082/202409 - periodic safety update report single assessmentNew
02/06/2025 PSUSA: PSUSA/00002235/202408 - periodic safety update report single assessmentNew
02/06/2025 Document: Process for the electronic submission of medicinal product information - Chapter 3Updated
02/06/2025 Document: Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescentsNew