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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. Information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products. This overview covers up to two months back.

As of 1 October 2025, information on medicines and related procedures includes a reference to relevant substances: INN or common name, active substance, and English common name for herbal products.

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Results (68)

Date	Content	Status
05/11/2026	Event: PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – December 2026	Updated
05/11/2026	PSUSA: PSUSA/00009144/202603 - periodic safety update report single assessment diethylamine-salicylate / escin	New
05/11/2026	Medicine: Suboxone buprenorphine; naloxone	Updated
05/11/2026	Medicine: Wayrilz rilzabrutinib	Updated
05/11/2026	Medicine: Voriconazole Accord voriconazole	Updated
05/11/2026	Medicine: Cosentyx secukinumab	Updated
05/11/2026	Medicine: Ogsiveo nirogacestat	Updated
05/11/2026	Medicine: Jyseleca filgotinib	Updated
05/11/2026	Page: Templates for assessors	Updated
05/11/2026	Document: Assessment report for PSUSA NAPs	New
05/11/2026	Document: Assessment report for PSUSA CAPs	New
05/11/2026	Page: Nitrosamine impurities: guidance for marketing authorisation holders	Updated
05/11/2026	Document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products	Updated
05/11/2026	Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations	Updated
05/11/2026	PSUSA: PSUSA/00001308/202603 - periodic safety update report single assessment ethinylestradiol / gestodene	New
05/11/2026	Document: Suboxone : EPAR - Scientific Discussion	Updated
05/11/2026	Document: Suboxone : EPAR - Procedural steps taken before authorisation	Updated
04/11/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
04/11/2026	Document: Ophthalmic devices ‐ other - Notified Body 0123 - 12/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)	New
04/11/2026	Document: Resorbable filling and reconstruction devices - Notified Body 2797 - 08/05/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)	New
04/11/2026	Event: Sixth Veterinary Big Data Stakeholder Forum	Updated
04/11/2026	Event: Digitalisation and artificial Intelligence in pharmaceutical manufacturing: Quality Innovation Group (QIG) - Follow-up roundtable meeting	Updated
04/11/2026	Event: EudraGMDP Q&A clinic for public users	New
04/11/2026	PIP: EMA/PE/0000257220 - paediatric investigation plan bempedoic acid; ezetimibe; atorvastatin	New
04/11/2026	PIP: EMA/PE/0000257216 - paediatric investigation plan bempedoic acid; ezetimibe; atorvastatin	New
04/11/2026	PIP: EMA/PE/0000253356 - paediatric investigation plan humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1-(((1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl)amino)-1,6,9,12,15-pentaoxo-3-oxa-5,8,11,14-tetraazahexadecan-16-yl)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)hexanamide	New
04/11/2026	PIP: EMA/PE/0000253047 - paediatric investigation plan encaleret	Updated
04/11/2026	PIP: EMA/PE/0000252649 - paediatric investigation plan inebilizumab	Updated
04/11/2026	PIP: EMA/PE/0000252572 - paediatric investigation plan ferumoxtran	Updated
04/11/2026	PIP: EMA/PE/0000249046 - paediatric investigation plan Guselkumab	Updated
04/11/2026	PIP: EMA/PE/0000248697 - paediatric investigation plan efzimfotase alfa	Updated
04/11/2026	PIP: EMA/PE/0000248263 - paediatric investigation plan leniolisib phosphate	Updated
04/11/2026	PIP: EMA/PE/0000248063 - paediatric investigation plan eslicarbazepine acetate	Updated
04/11/2026	PIP: EMA/PE/0000247449 - paediatric investigation plan lucerastat	Updated
04/11/2026	Medicine: Sugammadex Mylan sugammadex	Updated
04/11/2026	Medicine: Brukinsa zanubrutinib	Updated
04/11/2026	Medicine: Xromi hydroxycarbamide	Updated
04/11/2026	Document: Agenda of the CAT meeting 4-6 November 2026	New
04/11/2026	Document: Mandate, objectives and rules of procedure for the Scientific Advisory Groups (SAGs) and ad-hoc experts groups (AHEGs)	Updated
04/11/2026	Document: Agenda - HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations	Updated
04/11/2026	Medicine: Nylaspeg pegfilgrastim	Updated
04/11/2026	Page: Plasma master file certificates	Updated
04/11/2026	Medicine: Eravac rabbit haemorrhagic disease vaccine (inactivated)	Updated
04/11/2026	Document: Agenda - Stakeholder meeting, November 2026	New
04/11/2026	Page: Portfolio and technology meetings	Updated
04/11/2026	Page: Eligible healthcare professionals' organisations	Updated
04/11/2026	DHPC: Respreeza - direct healthcare professional communication (DHPC) human alpha1-proteinase inhibitor	New
04/11/2026	Page: Union list of critical medicines	Updated
04/11/2026	Document: Union list of critical medicines - version 2.1 (revision 2)	Updated
04/11/2026	Document: Highlights - 21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance	Updated
04/11/2026	Document: European Medicines Agency mid-year report 2026	New
03/11/2026	Medicine: Veanibek (previously Miglustat Gen.Orph) miglustat	Updated
03/11/2026	Medicine: Vlustozik (previously Ibuprofen Gen.Orph) ibuprofen	Updated
03/11/2026	Medicine: Bildyos denosumab	Updated
03/11/2026	Medicine: Sycrest asenapine	Updated
03/11/2026	Medicine: Rozlytrek entrectinib	Updated
03/11/2026	Medicine: Otulfi ustekinumab	Updated
03/11/2026	Post-authorisation: Truqap - withdrawal of application for variation to marketing authorisation capivasertib	New
03/11/2026	Medicine: Zokinvy lonafarnib	Updated
03/11/2026	Medicine: Rinvoq upadacitinib	Updated
03/11/2026	Document: Agenda of the COMP Meeting 3-5 November 2026	New
03/11/2026	Medicine: Liraglutide STADA liraglutide	Updated
03/11/2026	Medicine: Ablymico liraglutide	Updated
03/11/2026	Document: Organisation chart: Task Forces	Updated
03/11/2026	Document: Agenda of the CVMP meeting 3-5 November 2026	New
03/11/2026	Document: Nitrosamine Implementation Oversight Group Terms of Reference	Updated
03/11/2026	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
03/11/2026	Document: QRD Appendix V - Adverse-drug-reaction reporting details	Updated

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