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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.

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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.

Results (423)

Date	Content	Status
27/02/2026	PSUSA: PSUSA/00002709/202504 - periodic safety update report single assessment simvastatin	New
27/02/2026	Medicine: Ztalmy ganaxolone	Updated
27/02/2026	Medicine: Epidyolex cannabidiol	Updated
27/02/2026	Medicine: Jeraygo aprocitentan	Updated
27/02/2026	Event: Meeting of the HMA-EMA group focused on AI with industry stakeholders - February 2026	New
27/02/2026	Medicine: Zyprexa olanzapine	Updated
27/02/2026	Event: Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability	New
27/02/2026	Medicine: Aumseqa Aumolertinib	Updated
27/02/2026	Event: EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU	Updated
27/02/2026	Medicine: Comirnaty COVID-19 mRNA vaccine	Updated
27/02/2026	Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine	Updated
27/02/2026	Page: EU Innovation Network (EU-IN)	Updated
27/02/2026	Medicine: Nustendi bempedoic acid; ezetimibe	Updated
27/02/2026	Medicine: Nilemdo bempedoic acid	Updated
27/02/2026	Medicine: Alecensa alectinib	Updated
27/02/2026	Medicine: Cometriq cabozantinib	Updated
27/02/2026	Medicine: Cabometyx cabozantinib	Updated
27/02/2026	Document: Agenda of the HMPC meeting 2-4 March 2026	New
27/02/2026	Page: Orphan designation: Overview	Updated
27/02/2026	Document: List of centrally authorised products with safety-related changes to the product information	Updated
27/02/2026	Medicine: Onerji levodopa; carbidopa	New
27/02/2026	Medicine: Ojemda tovorafenib	New
27/02/2026	Medicine: Fubelv etanercept	New
27/02/2026	Medicine: Tuyory tocilizumab	New
27/02/2026	Medicine: Rhapsido remibrutinib	New
27/02/2026	Medicine: Bysumlog insulin lispro	New
27/02/2026	Medicine: Dazparda insulin aspart	New
27/02/2026	Medicine: Palsonify paltusotine	New
27/02/2026	Medicine: mCOMBRIAX Influenza; COVID-19 mRNA vaccine	New
27/02/2026	Medicine: Poherdy pertuzumab	New
27/02/2026	Medicine: Iloperidone Vanda Pharmaceuticals iloperidone	New
27/02/2026	Medicine: Daybu trofinetide	New
27/02/2026	Medicine: Zumrad sasanlimab	New
27/02/2026	Medicine: Zandoriah teriparatide	New
27/02/2026	Medicine: Xolremdi mavorixafor	New
27/02/2026	News: New single-dose oral treatment for human African trypanosomiasis (sleeping sickness)	New
27/02/2026	News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026	New
27/02/2026	Post-authorisation: Dupixent - opinion on variation to marketing authorisation dupilumab	New
27/02/2026	Post-authorisation: Keytruda - opinion on variation to marketing authorisation pembrolizumab	New
27/02/2026	Post-authorisation: Olumiant - opinion on variation to marketing authorisation baricitinib	New
27/02/2026	Post-authorisation: Scemblix - opinion on variation to marketing authorisation asciminib	New
27/02/2026	Post-authorisation: Stelara - opinion on variation to marketing authorisation ustekinumab	New
27/02/2026	Post-authorisation: Jorveza - opinion on variation to marketing authorisation budesonide	New
27/02/2026	EU-M4all: Acoziborole Winthrop - opinion on medicine for use outside EU acoziborole	New
27/02/2026	Document: Info sheet - Orphan medicines in the EU	Updated
27/02/2026	News: New medicine to treat paediatric low-grade glioma	New
27/02/2026	Referral: Tecovirimat SIGA - referral tecovirimat	Updated
27/02/2026	Medicine: Flucelvax Tetra influenza vaccine (surface antigen, inactivated, prepared in cell cultures)	Updated
26/02/2026	Medicine: Taltz ixekizumab	Updated
26/02/2026	Medicine: Evkeeza evinacumab	Updated
26/02/2026	Medicine: Mounjaro tirzepatide	Updated
26/02/2026	Document: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) annual activity report 2025	New
26/02/2026	Document: Minutes of the Management Board meeting: 17-18 December 2025	New
26/02/2026	Medicine: Yeytuo lenacapavir	Updated
26/02/2026	Document: European Medicines Agency (EMA) stakeholder relations management framework	Updated
26/02/2026	Medicine: Adenuric febuxostat	Updated
26/02/2026	Medicine: Remsima infliximab	Updated
26/02/2026	Medicine: Sunlenca lenacapavir	Updated
26/02/2026	Medicine: Fluad Tetra influenza vaccine (surface antigen, inactivated, adjuvanted)	Updated
26/02/2026	Document: Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance Veterinary	Updated
26/02/2026	Medicine: Conexxence denosumab	Updated
26/02/2026	Medicine: Kisunla donanemab	Updated
26/02/2026	Referral: Melatomed and associated names - referral melatonin	Updated
26/02/2026	Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC	Updated
26/02/2026	Medicine: Revolade eltrombopag	Updated
26/02/2026	Medicine: Vydura rimegepant	Updated
26/02/2026	Medicine: Yesafili aflibercept	Updated
25/02/2026	PIP: EMA/PE/0000226657 - paediatric investigation plan abelacimab	Updated
25/02/2026	PIP: EMA/PE/0000226303 - paediatric investigation plan naldemedine tosilate	Updated
25/02/2026	PIP: EMEA-003395-PIP02-23 - paediatric investigation plan iodine (131I) apamistamab	Updated
25/02/2026	PIP: EMEA-001238-PIP02-20 - paediatric investigation plan vatiquinone	Updated
25/02/2026	Medicine: Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A. Epizootic haemorrhagic disease vaccine (recombinant protein)	Updated
25/02/2026	Medicine: Kavigale sipavibart	Updated
25/02/2026	Medicine: Steqeyma ustekinumab	Updated
25/02/2026	Page: Fees payable to the European Medicines Agency: Guidance for all applicants	Updated
25/02/2026	Medicine: Sycrest asenapine	Updated
25/02/2026	Medicine: Daxas roflumilast	Updated
25/02/2026	Medicine: DaTSCAN ioflupane (123l)	Updated
25/02/2026	Medicine: Eltrombopag Accord eltrombopag	Updated
25/02/2026	Medicine: Tadalafil Mylan tadalafil	Updated
25/02/2026	Medicine: Byooviz ranibizumab	Updated
25/02/2026	Medicine: Hepcludex bulevirtide	Updated
25/02/2026	Medicine: Tibsovo ivosidenib	Updated
25/02/2026	Medicine: Qaialdo spironolactone	Updated
25/02/2026	Page: List of medicines under additional monitoring	Updated
25/02/2026	Document: List of medicinal products under additional monitoring	Updated
25/02/2026	Document: List of medicinal products under additional monitoring	Updated
25/02/2026	Medicine: Verzenios abemaciclib	Updated
25/02/2026	Medicine: CellCept mycophenolate mofetil	Updated
25/02/2026	Medicine: Sprycel dasatinib (anhydrous)	Updated
25/02/2026	Medicine: Gotenfia golimumab	Updated
25/02/2026	Event: Cancer Medicines Forum: December 2025	New
25/02/2026	Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2026	Updated
25/02/2026	PIP: EMEA-003618-PIP01-24 - paediatric investigation plan 2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione	New
24/02/2026	Document: Electronic reporting to EudraVigilance - List of reference documents	New
24/02/2026	Page: EudraVigilance: electronic reporting	Updated
24/02/2026	Medicine: Vivlipeg pegfilgrastim	Updated
24/02/2026	Medicine: Enzalutamide Viatris enzalutamide	Updated
24/02/2026	Page: EudraVigilance training and support	Updated
24/02/2026	Shortage: Cyclophosphamide cyclophosphamide	New
24/02/2026	Document: EudraVigilance support guide	Updated
24/02/2026	Document: EudraVigilance - EVWEB user manual	Updated
24/02/2026	Medicine: Exelon rivastigmine	Updated
24/02/2026	Shortage: Ifosfamide ifosfamide	Updated
24/02/2026	Medicine: Erleada apalutamide	Updated
24/02/2026	Page: ICH E22 General considerations for patient preference studies - Scientific guideline	Updated
24/02/2026	Medicine: Zoledronic Acid Accord zoledronic acid	Updated
24/02/2026	Page: Website outages and upgrades	Updated
24/02/2026	Medicine: Apixaban Accord apixaban	Updated
24/02/2026	Medicine: Teriflunomide Accord teriflunomide	Updated
24/02/2026	Medicine: Eribulin Baxter eribulin	Updated
24/02/2026	Medicine: Acvybra denosumab	Updated
24/02/2026	Medicine: Lenalidomide Accord lenalidomide	Updated
24/02/2026	Medicine: Fymskina ustekinumab	Updated
24/02/2026	Medicine: Ranluspec ranibizumab	Updated
24/02/2026	Medicine: Tivdak tisotumab vedotin	Updated
24/02/2026	Medicine: Tepadina thiotepa	Updated
24/02/2026	Document: Agenda - Webinar on the use of platform approaches in the non-clinical and clinical domains	Updated
24/02/2026	Medicine: Fintepla fenfluramine	Updated
24/02/2026	Page: ICH Q14 Analytical procedure development - Scientific guideline	Updated
24/02/2026	Document: European Medicines Agency’s data protection notice for the operation of the Security Access Control System	Updated
24/02/2026	Document: Record of data processing activity relating to Security Access Control System	Updated
24/02/2026	Event: Product Management Service (PMS) information day 2026	Updated
24/02/2026	Document: Agenda - PDCO agenda of the 24-27 February 2026 meeting	New
23/02/2026	PIP: EMA/PE/0000257243 - paediatric investigation plan pozelimab	Updated
23/02/2026	PIP: EMA/PE/0000231113 - paediatric investigation plan nemvaleukin alfa	Updated
23/02/2026	Referral: Ipidacrine-containing medicinal products - referral ipidacrine	Updated
23/02/2026	Medicine: Inluriyo imlunestrant	Updated
23/02/2026	Medicine: Efmody hydrocortisone	Updated
23/02/2026	Medicine: Ogivri trastuzumab	Updated
23/02/2026	Shortage: Natpar parathyroid hormone	Updated
23/02/2026	Medicine: Entyvio vedolizumab	Updated
23/02/2026	Medicine: Emblaveo aztreonam; avibactam	Updated
23/02/2026	Medicine: Beyfortus nirsevimab	Updated
23/02/2026	Document: Agenda of the CHMP meeting 23-26 February 2026	New
23/02/2026	Document: Annex to agenda of the CHMP meeting 23-26 February 2026	New
20/02/2026	Medicine: Dawnzera donidalorsen	Updated
20/02/2026	Page: ICH M4Q - The Common Technical Document for the registration of pharmaceuticals for human use - Quality - Scientific guideline	Updated
20/02/2026	Document: Overview of comments on ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b	New
20/02/2026	Event: Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2026	Updated
20/02/2026	Document: Minutes of the CVMP meeting 13-15 January 2026	New
20/02/2026	Document: Minutes of the CVMP meeting 2-4 December 2025	New
20/02/2026	Medicine: Osqay denosumab	Updated
20/02/2026	Medicine: Semglee insulin glargine	Updated
20/02/2026	Document: Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products	Updated
20/02/2026	Medicine: Teizeild teplizumab	Updated
20/02/2026	Medicine: Vfend voriconazole	Updated
20/02/2026	Page: Guideline on quality aspects of mRNA vaccines for veterinary use	Updated
20/02/2026	EU-M4all: Lenacapavir Gilead - opinion on medicine for use outside EU lenacapavir	Updated
20/02/2026	Page: ICH Q2(R2) Validation of analytical procedures - Scientific guideline	Updated
20/02/2026	News: Recruitment procedure opens for next Executive Director of the European Medicines Agency	New
20/02/2026	Medicine: Apremilast Accord apremilast	Updated
20/02/2026	Document: Draft guideline on quality aspects of mRNA vaccines for veterinary use	New
20/02/2026	PSUSA: PSUSA/00001307/202507 - periodic safety update report single assessment ethinylestradiol / etonogestrel	New
20/02/2026	Medicine: Palonosetron Accord palonosetron	Updated
20/02/2026	Medicine: Lyvdelzi (previously Seladelpar Gilead) seladelpar lysine dihydrate	Updated
20/02/2026	Medicine: Kevzara sarilumab	Updated
20/02/2026	Medicine: Ameluz 5-aminolevulinic acid hydrochloride	Updated
20/02/2026	Page: Risk management requirements for elemental impurities in veterinary medicinal products - Scientific guideline	Updated
19/02/2026	Medicine: Casgevy exagamglogene autotemcel	Updated
19/02/2026	Medicine: Dovprela (previously Pretomanid FGK) pretomanid	Updated
19/02/2026	Medicine: Lynparza olaparib	Updated
19/02/2026	Medicine: Waskyra etuvetidigene autotemcel	Updated
19/02/2026	Medicine: Imfinzi durvalumab	Updated
19/02/2026	Medicine: Klisyri tirbanibulin	Updated
19/02/2026	Medicine: Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted)	Updated
19/02/2026	Medicine: Uptravi selexipag	Updated
19/02/2026	Medicine: Kigabeq vigabatrin	Updated
19/02/2026	Medicine: Adzynma rADAMTS13	Updated
19/02/2026	Medicine: Enrylaze crisantaspase	Updated
19/02/2026	Document: Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder group	Updated
19/02/2026	Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026	New
19/02/2026	Medicine: Soliris eculizumab	Updated
19/02/2026	Medicine: Fulphila pegfilgrastim	Updated
19/02/2026	Medicine: Sibnayal potassium citrate; potassium hydrogen carbonate	Updated
19/02/2026	Medicine: Mysimba naltrexone; bupropion	Updated
19/02/2026	Medicine: Evfraxy denosumab	Updated
19/02/2026	Medicine: Hulio adalimumab	Updated
18/02/2026	Event: Committee for Advanced Therapies (CAT): 18-20 February 2026	Updated
18/02/2026	Document: Agenda of the CAT meeting 18-20 February 2026	New
18/02/2026	Event: European Medicines Regulatory Network (EMRN) workshop on Geographic Atrophy endpoints	Updated
18/02/2026	Medicine: Orladeyo berotralstat	Updated
18/02/2026	Medicine: Zemcelpro allogeneic umbilical cord-derived CD34- cells, non-expanded; dorocubicel	Updated
18/02/2026	Medicine: Pluvicto lutetium (177Lu) vipivotide tetraxetan	Updated
18/02/2026	Medicine: Epysqli eculizumab	Updated
18/02/2026	Page: Podcast: Inside EMA	Updated
18/02/2026	Medicine: Wezenla ustekinumab	Updated
18/02/2026	Medicine: Cejemly sugemalimab	Updated
18/02/2026	Document: Vaccine Monitoring Platform: List of EMA-funded studies	Updated
17/02/2026	Medicine: Vevzuo denosumab	Updated
17/02/2026	Shortage: Trulicity dulaglutide	Updated
17/02/2026	Event: ACT EU multi-stakeholder platform annual meeting	Updated
17/02/2026	Medicine: Inflectra infliximab	Updated
17/02/2026	Document: Scientific advice and protocol assistance adopted during the CHMP meeting 26-29 January 2026	New
17/02/2026	Medicine: Uplizna inebilizumab	Updated
17/02/2026	Medicine: Arexvy recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E	Updated
17/02/2026	Medicine: Bronchitol mannitol	Updated
17/02/2026	Medicine: Trecondi treosulfan	Updated
17/02/2026	Medicine: Imbruvica ibrutinib	Updated
17/02/2026	Page: Immune and Inflammatory Diseases Working Party (IIWP)	Updated
17/02/2026	Document: Agenda - Medicine Shortages SPOC Working Party meeting 17 February 2026	New
17/02/2026	Medicine: Usrenty ustekinumab	Updated
17/02/2026	PSUSA: PSUSA/00010876/202506 - periodic safety update report single assessment amlodipine / irbesartan	New
16/02/2026	Document: Minutes of the CHMP meeting 21-24 July 2025	Updated
16/02/2026	Document: Minutes of the CHMP meeting 19-22 May 2025	Updated
16/02/2026	Page: Clinical Pharmacology Operational Expert Group	New
16/02/2026	Medicine: Lunsumio mosunetuzumab	Updated
16/02/2026	PSUSA: PSUSA/00010606/202506 - periodic safety update report single assessment itopride	New
16/02/2026	Medicine: Vaxelis diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)	Updated
16/02/2026	Medicine: Pregabalin Zentiva pregabalin	Updated
16/02/2026	Event: Committee for Orphan Medicinal Products (COMP): 17-19 February 2026	Updated
16/02/2026	Medicine: Orphacol cholic acid	Updated
16/02/2026	Medicine: Dovato dolutegravir; lamivudine	Updated
16/02/2026	PSUSA: PSUSA/00010572/202506 - periodic safety update report single assessment nitrous oxide / oxygen	New
16/02/2026	Medicine: Luxturna voretigene neparvovec	Updated
16/02/2026	Medicine: Jemperli dostarlimab	Updated
16/02/2026	Document: Overview of comments received on Q&A regarding co-processed excipients used in solid oral dosage forms H and V (EMA/CHMP/CVMP/QWP/422493/2024)	Updated
16/02/2026	Page: ICH E20 adaptive designs for clinical trials - Scientific guideline	Updated
16/02/2026	Document: HMA-EMA joint Network Data Steering Group meeting - 13 January 2026	New
16/02/2026	Document: PDCO minutes of the 9-12 December 2025 meeting	New
16/02/2026	Medicine: Yesintek ustekinumab	Updated
16/02/2026	PSUSA: PSUSA/00002042/202507 - periodic safety update report single assessment chlorquinaldol / metronidazole	New
16/02/2026	Page: Good pharmacovigilance practices (GVP)	Updated
16/02/2026	Medicine: Hefiya adalimumab	Updated
16/02/2026	Medicine: Ibuprofen Gen.Orph ibuprofen	Updated
16/02/2026	Medicine: Enspryng satralizumab	Updated
16/02/2026	PSUSA: PSUSA/00009225/202506 - periodic safety update report single assessment magnesium sulfate	New
16/02/2026	PSUSA: PSUSA/00000080/202506 - periodic safety update report single assessment alfacalcidol	New
16/02/2026	Herbal: Ribis nigri folium - herbal medicinal product Blackcurrant Leaf	Updated
16/02/2026	Document: Draft European Union herbal monograph on Ribes nigrum L., folium - Revision 2	New
13/02/2026	Medicine: Emepax maropitant	New
13/02/2026	News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 February 2026	New
13/02/2026	Post-authorisation: Suvaxyn PRRS MLV - opinion on variation to marketing authorisation porcine respiratory and reproductive syndrome virus, live	New
13/02/2026	Post-authorisation: Bluevac BTV (previously Bluevac BTV8) - opinion on variation to marketing authorisation	New
13/02/2026	Document: Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)	New
13/02/2026	Document: Highlights - 6th EMA-AESGP bilateral meeting	New
13/02/2026	Document: Medicinal products for human use: monthly figures - January 2026	New
13/02/2026	Medicine: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris emtricitabine; rilpivirine; tenofovir alafenamide	Updated
13/02/2026	Medicine: Xerava eravacycline	Updated
13/02/2026	Referral: Levamisole-containing medicinal products - referral levamisole	Updated
13/02/2026	News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026	New
13/02/2026	News: EMA recommends withdrawal of marketing authorisations for levamisole medicines	New
13/02/2026	Page: Medicine shortage communications (MSC)	Updated
13/02/2026	Document: Medicine shortage communication (MSC): Natpar (parathyroid hormone) (25, 50, 75 and 100 micrograms/dose powder and solvent for solution for injection)	New
13/02/2026	Page: Clinical investigation of medicinal products in the treatment of Myasthenia Gravis	New
13/02/2026	Document: Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis	New
12/02/2026	Page: Paediatric investigation plans: questions and answers	Updated
12/02/2026	Document: Review of the stepwise paediatric investigation plan (sPIP) pilot: Outcomes and future perspectives	New
12/02/2026	Page: Paediatric investigation plans	Updated
12/02/2026	Medicine: Vantavo (previously Alendronate sodium and colecalciferol, MSD) alendronic acid; colecalciferol	Updated
12/02/2026	Medicine: Palforzia defatted powder of Arachis hypogaea L., semen (peanuts)	Updated
12/02/2026	Event: Quarterly System Demo - Q1 2026	Updated
12/02/2026	PSUSA: PSUSA/00002076/202506 - periodic safety update report single assessment mitoxantrone	New
12/02/2026	PSUSA: PSUSA/00000812/202506 - periodic safety update report single assessment clonazepam	New
12/02/2026	PSUSA: PSUSA/00002639/202507 - periodic safety update report single assessment rifabutin	New
12/02/2026	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026	Updated
12/02/2026	Document: Guidance for applicants for the preparation of the precise scope section of the variation application form	Updated
12/02/2026	Medicine: Infanrix Hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)	Updated
12/02/2026	Medicine: Retsevmo selpercatinib	Updated
12/02/2026	Medicine: Adrovance alendronic acid; colecalciferol	Updated
12/02/2026	PSUSA: PSUSA/00001516/202506 - periodic safety update report single assessment ganciclovir	New
12/02/2026	PSUSA: PSUSA/00010291/202506 - periodic safety update report single assessment misoprostol (gastrointestinal indication)	New
12/02/2026	PSUSA: PSUSA/00001499/202502 - periodic safety update report single assessment gabapentin	Updated
12/02/2026	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026	Updated
12/02/2026	Medicine: Glyxambi empagliflozin; linagliptin	Updated
12/02/2026	Medicine: Jentadueto linagliptin; metformin hydrochloride	Updated
12/02/2026	Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23	Updated
12/02/2026	Medicine: Trajenta linagliptin	Updated
12/02/2026	Event: 16th Industry Standing Group (ISG) meeting	New
12/02/2026	Medicine: Foscan temoporfin	Updated
12/02/2026	Medicine: Fosavance alendronic acid; colecalciferol	Updated
12/02/2026	Medicine: Kyinsu insulin icodec; semaglutide	Updated
12/02/2026	Document: Minutes of the PRAC meeting 24 - 27 November 2025	New
12/02/2026	Event: SPOR and XEVMPD status update webinar - Q1 2026	Updated
12/02/2026	Medicine: Kapruvia difelikefalin	Updated
12/02/2026	Document: Antimicrobial Sales and Use (ASU) Platform: Release notes	Updated
12/02/2026	Document: Organisation chart: Human Medicines	Updated
12/02/2026	PSUSA: PSUSA/00002908/202412 - periodic safety update report single assessment testosterone (topical use)	New
11/02/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 21-24 July 2025	Updated
11/02/2026	Document: Annex to 21-24 July 2025 CHMP Minutes	New
11/02/2026	Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party	Updated
11/02/2026	Document: Minutes - 2025 annual internal meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (EnprEMA)	New
11/02/2026	Medicine: Siklos hydroxycarbamide	Updated
11/02/2026	PSUSA: PSUSA/00000662/202503 - periodic safety update report single assessment chlorhexidine	New
11/02/2026	Herbal: Oenotherae oleum - herbal medicinal product Evening primrose oil	Updated
11/02/2026	Herbal: Cimicifugae rhizoma - herbal medicinal product Black Cohosh	Updated
11/02/2026	Medicine: Imjudo tremelimumab	Updated
11/02/2026	Medicine: Steglatro ertugliflozin	Updated
11/02/2026	Medicine: Sephience sepiapterin	Updated
11/02/2026	Medicine: Romvimza vimseltinib	Updated
11/02/2026	Medicine: Qinlock ripretinib	Updated
11/02/2026	Medicine: Lumark lutetium (177Lu) chloride	Updated
11/02/2026	Medicine: HyQvia human normal immunoglobulin	Updated
11/02/2026	Page: Extended EudraVigilance medicinal product dictionary (XEVMPD) training	Updated
11/02/2026	Medicine: Plegridy peginterferon beta-1a	Updated
11/02/2026	Shortage: Norditropin FlexPro / Norditropin NordiFlex somatropin	Updated
11/02/2026	Page: ICH M15 guideline on general principles for model-informed drug development - Scientific guideline	Updated
11/02/2026	Document: ICH M15 Guideline on general principles for model-informed drug development - Step 5	New
10/02/2026	Medicine: Elucirem gadopiclenol	Updated
10/02/2026	Medicine: Vueway gadopiclenol	Updated
10/02/2026	Page: Aliskiren product-specific bioequivalence guidance	Updated
10/02/2026	Document: PhV non-compliance notification contact points at National Competent Authority (NCA) level	Updated
10/02/2026	Document: Agenda of the CVMP meeting 10-12 February 2026	New
10/02/2026	Medicine: Winlevi clascoterone	Updated
10/02/2026	Document: Annex to 16-19 June 2025 CHMP Minutes	New
10/02/2026	Document: Minutes of the CHMP meeting 16-19 June 2025	New
10/02/2026	Medicine: Carvykti ciltacabtagene autoleucel	Updated
10/02/2026	Document: Article 57 product data	Updated
10/02/2026	Document: List of eligible industry stakeholder organisations	Updated
10/02/2026	Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)	Updated
10/02/2026	Page: Ledipasvir/sofosbuvir product-specific bioequivalence guidance	Updated
10/02/2026	Medicine: Piasky crovalimab	Updated
10/02/2026	Document: Validation checklist for Type II quality variations	Updated
09/02/2026	Medicine: Datroway datopotamab deruxtecan	Updated
09/02/2026	Medicine: Lytenava bevacizumab	Updated
09/02/2026	Document: Agenda of the PRAC meeting 9-12 February 2026	New
09/02/2026	Page: Plasma master file certificates	Updated
09/02/2026	DHPC: Arixtra - direct healthcare professional communication (DHPC) fondaparinux sodium	New
09/02/2026	Shortage: Tresiba insulin degludec	Updated
09/02/2026	Document: Minutes of the COMP meeting 2-3 December 2025	New
09/02/2026	Medicine: Zypadhera olanzapine	Updated
09/02/2026	Medicine: Azopt brinzolamide	Updated
09/02/2026	Medicine: Xadago safinamide	Updated
09/02/2026	Event: Third European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting	Updated
09/02/2026	Document: PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC meeting	New
09/02/2026	Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC	New
09/02/2026	Document: Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation	New
09/02/2026	Document: List of signals discussed at PRAC since September 2012	Updated
06/02/2026	Document: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes	New
06/02/2026	Document: Comments received from public consultation on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women (EMA/653036/2019)	New
06/02/2026	Document: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk	New
06/02/2026	Document: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk	New
06/02/2026	Page: Archive of development of good pharmacovigilance practices	Updated
06/02/2026	Page: Fees for veterinary medicines	Updated
06/02/2026	Page: Fees for human medicines	Updated
06/02/2026	Document: Highlights – 1st European Medicine Agency (EMA) and European Respiratory Society (ERS) bilateral meeting	New
06/02/2026	Medicine: Bildyos denosumab	Updated
06/02/2026	Medicine: Tepkinly epcoritamab	Updated
06/02/2026	Medicine: Helicobacter Test INFAI 13C-urea	Updated
06/02/2026	Medicine: Tuznue trastuzumab	Updated
06/02/2026	Medicine: Cibinqo abrocitinib	Updated
06/02/2026	Medicine: Exforge HCT amlodipine besilate; valsartan; hydrochlorothiazide	Updated
06/02/2026	Medicine: Alymsys bevacizumab	Updated
06/02/2026	Medicine: Dafiro HCT amlodipine besilate; valsartan; hydrochlorothiazide	Updated
06/02/2026	Medicine: Copalia HCT amlodipine; valsartan; hydrochlorothiazide	Updated
06/02/2026	Page: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices	Updated
06/02/2026	Page: Annual fees payable to the European Medicines Agency	Updated
06/02/2026	Page: Combination Products Operational Group: agendas and highlight reports	Updated
06/02/2026	Document: Agenda - Combination products operational group, In vitro diagnostics (IVD) stream, 9 February 2026	New
06/02/2026	Document: Agenda - Combination products operational group, Medical devices (MD) stream, 12 February 2026	New
06/02/2026	Event: Webinar on the use of platform approaches in the non-clinical and clinical domains	Updated
06/02/2026	Document: Overview of (invented) names reviewed in November 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 11 December 2025	Updated
06/02/2026	Medicine: Rayvow lasmiditan	Updated
06/02/2026	Page: Medicine shortages and availability issues	Updated
06/02/2026	Page: Drug Shortages Global Regulatory Working Group	Updated
06/02/2026	PSUSA: PSUSA/00003006/202503 - periodic safety update report single assessment tranexamic acid	New
06/02/2026	Medicine: Insulin aspart Sanofi insulin aspart	Updated
06/02/2026	Page: COVID-19 vaccines: key facts	Updated
06/02/2026	Event: LinkedIn Live: How EMA supports innovation in medicine development	New
06/02/2026	Page: Medicines during pregnancy and breastfeeding	Updated
06/02/2026	Medicine: Azarga brinzolamide; timolol	Updated
06/02/2026	Document: Drug Shortages Global Regulatory Working Group: Group statement published on behalf of the Working Group by EMA	New
05/02/2026	Medicine: Eltrombopag Viatris eltrombopag	Updated
05/02/2026	Medicine: Exjade deferasirox	Updated
05/02/2026	Medicine: Dasatinib Accord Healthcare dasatinib	Updated
05/02/2026	Medicine: Kesimpta ofatumumab	Updated
05/02/2026	Medicine: Clopidogrel Zentiva (previously Clopidogrel Winthrop) clopidogrel	Updated
05/02/2026	Page: PRIME: priority medicines	Updated
05/02/2026	Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 26-29 January 2026	Updated
05/02/2026	Medicine: Vanflyta quizartinib	Updated
05/02/2026	Medicine: Yuvanci macitentan; tadalafil	Updated
05/02/2026	Medicine: Vazkepa icosapent ethyl	Updated
05/02/2026	Medicine: Lyxumia lixisenatide	Updated
05/02/2026	Medicine: Yuflyma adalimumab	Updated
05/02/2026	Event: Committee for Advanced Therapies (CAT): 3-5 December 2025	Updated
05/02/2026	Document: Applications for new human medicines under evaluation: February 2026	New
05/02/2026	Medicine: DuoTrav travoprost; timolol	Updated
05/02/2026	Document: List of medicines currently in PRIME scheme	Updated
05/02/2026	Medicine: Avzivi bevacizumab	Updated
05/02/2026	Medicine: Spevigo spesolimab	Updated
05/02/2026	Document: Procedural advice for vaccine platform technology master file (vPTMF) certification	Updated
05/02/2026	Document: Procedural advice for veterinary vaccine antigen master file (VAMF) certification	Updated
05/02/2026	Medicine: Wegovy semaglutide	Updated
05/02/2026	Medicine: Tocilizumab STADA (previously Tofidence) tocilizumab	Updated
05/02/2026	Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 19-21 January 2026	New
05/02/2026	Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV)	Updated
05/02/2026	Medicine: Prevenar 13 pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)	Updated
04/02/2026	Document: Start of procedure: Extension of marketing authorisation (12 December 2025 - 29 January 2026)	New
04/02/2026	Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (12 December 2025 - 29 January 2026)	New
04/02/2026	Event: Industry stakeholder webinar on revised environmental risk assessment guideline for medicinal products for human use - 1 year experience	Updated
04/02/2026	Medicine: Kirsty (previously Kixelle) insulin aspart	Updated
04/02/2026	Medicine: Sugammadex Amomed sugammadex	Updated
04/02/2026	Page: Epidemiological data on blood transmissible infections - Scientific guideline	Updated
04/02/2026	Document: Committee for Advanced Therapies (CAT): Work Plan 2026	New
04/02/2026	Page: Interested Parties to the HMPC	Updated
04/02/2026	Document: Hearing the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2025 meeting	New
04/02/2026	Document: PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template	Updated
04/02/2026	Document: Template PRAC assessment report of an non-interventional imposed PASS final study report	Updated
04/02/2026	Medicine: Leqembi lecanemab	Updated
04/02/2026	Page: National competent authorities (human)	Updated
04/02/2026	Medicine: Imraldi adalimumab	Updated
04/02/2026	Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)	Updated
04/02/2026	Document: Plasma Master File (PMF) requirements - questions and answers for PMF holders	Updated
03/02/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
03/02/2026	Medicine: Sapropterin Dipharma sapropterin	Updated
03/02/2026	Medicine: Gilenya fingolimod	Updated
03/02/2026	Document: Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC)	Updated
03/02/2026	Document: CHMP work plan 2026	New
03/02/2026	Medicine: Uzpruvo ustekinumab	Updated
03/02/2026	Medicine: Trazimera trastuzumab	Updated
03/02/2026	Medicine: GalliaPharm gallium (68Ga) chloride; germanium (68Ge) chloride	Updated
02/02/2026	Document: Training module EV-M8 - Considerations on the international transfer of personal (health) data in ICSRs -SUSARs originating in the EU	Updated
02/02/2026	Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)	Updated
02/02/2026	Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)	Updated
02/02/2026	Document: COMP work plan 2026	New
02/02/2026	Page: Qualification of non-mutagenic impurities - Scientific guideline	Updated
02/02/2026	Event: EMA Veterinary Medicines Info Day 2026	Updated
02/02/2026	Document: Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 17 December 2025	New
02/02/2026	Event: 15th industry stakeholder platform on research and development support	Updated
02/02/2026	Document: Recommended submission dates for veterinary medicinal products	Updated
02/02/2026	Document: Union Product Database (UPD) registration guide for UI and API users	Updated
02/02/2026	Page: Human Medicines	Updated
02/02/2026	Page: EU enlargement	Updated

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