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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 (548)

Date	Content	Status
19/12/2025	Page: Plasma master file certificates	Updated
19/12/2025	PSUSA: PSUSA/00010473/202503 - periodic safety update report single assessment varicella vaccine (live)	New
19/12/2025	PSUSA: PSUSA/00010473/202503 - periodic safety update report single assessment varicella vaccine (live)	New
19/12/2025	Medicine: Avastin bevacizumab	Updated
19/12/2025	Medicine: Fabhalta iptacopan	Updated
19/12/2025	Medicine: Attrogy diflunisal	Updated
19/12/2025	Medicine: Tremfya guselkumab	Updated
19/12/2025	Medicine: Rotarix rotavirus vaccine, live	Updated
19/12/2025	Medicine: Olumiant baricitinib	Updated
19/12/2025	Medicine: Minjuvi tafasitamab	Updated
19/12/2025	Medicine: Shingrix herpes zoster vaccine (recombinant, adjuvanted)	Updated
19/12/2025	Medicine: Replagal agalsidase alfa	Updated
19/12/2025	Medicine: Pregabalin Viatris (previously Pregabalin Mylan) pregabalin	Updated
19/12/2025	Medicine: Tuzulby methylphenidate hydrochloride	Updated
19/12/2025	Medicine: Leflunomide medac leflunomide	Updated
19/12/2025	PSUSA: PSUSA/00002688/202503 - periodic safety update report single assessment selegiline	New
19/12/2025	PSUSA: PSUSA/00002656/202502 - periodic safety update report single assessment Rocuronium	New
19/12/2025	News: Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation	New
19/12/2025	News: EMA Management Board: highlights of December 2025 meeting	New
19/12/2025	News: EMA business hours over holiday period	New
19/12/2025	Medicine: Yargesa miglustat	Updated
19/12/2025	Medicine: Simulect basiliximab	Updated
19/12/2025	Medicine: Macitentan AccordPharma macitentan	Updated
19/12/2025	PSUSA: PSUSA/00002640/202503 - periodic safety update report single assessment rifampicin	New
19/12/2025	Medicine: Methylthioninium chloride Proveblue methylthioninium chloride	Updated
19/12/2025	Medicine: Ruconest conestat alfa	Updated
19/12/2025	Medicine: Altuvoct efanesoctocog alfa	Updated
19/12/2025	PSUSA: PSUSA/00002039/202503 - periodic safety update report single assessment metoprolol	New
19/12/2025	Medicine: Pirfenidone Viatris pirfenidone	Updated
19/12/2025	Post-authorisation: Hetlioz - opinion on variation to marketing authorisation tasimelteon	Updated
19/12/2025	Medicine: Macitentan Accord macitentan	Updated
19/12/2025	Medicine: Comirnaty COVID-19 mRNA vaccine	Updated
19/12/2025	Page: Information management	Updated
19/12/2025	Document: Technology Capability Investment Plan to 2028 - Becoming a digital hub for the European medicines regulator network	New
18/12/2025	Medicine: Afqlir aflibercept	Updated
18/12/2025	PSUSA: PSUSA/00002502/202503 - periodic safety update report single assessment prazepam	New
18/12/2025	Medicine: Puregon follitropin beta	Updated
18/12/2025	Medicine: Fetcroja cefiderocol	Updated
18/12/2025	Medicine: RotaTeq rotavirus vaccine, live	Updated
18/12/2025	Medicine: Orgalutran ganirelix	Updated
18/12/2025	Event: EMA - European Consumer Organisation (BEUC) bilateral meeting	Updated
18/12/2025	Medicine: Jentadueto linagliptin; metformin hydrochloride	Updated
18/12/2025	Medicine: Cetrotide cetrorelix	Updated
18/12/2025	Page: PRIME: priority medicines	Updated
18/12/2025	Document: List of medicines currently in PRIME scheme	Updated
18/12/2025	Medicine: Absimky ustekinumab	Updated
18/12/2025	Medicine: Saphnelo anifrolumab	Updated
18/12/2025	Medicine: Blarcamesine Anavex blarcamesine	Updated
18/12/2025	Medicine: Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence	Updated
18/12/2025	Medicine: Qtern saxagliptin; dapagliflozin	Updated
18/12/2025	Medicine: Xigduo dapagliflozin; metformin	Updated
18/12/2025	Medicine: Ebymect dapagliflozin; metformin	Updated
18/12/2025	Medicine: Cosentyx secukinumab	Updated
18/12/2025	Medicine: Leflunomide ratiopharm leflunomide	Updated
18/12/2025	Document: Agenda - Management Board meeting: 17-18 December 2025	Updated
18/12/2025	Medicine: Mepact mifamurtide	Updated
18/12/2025	Document: Minutes of the PRAC meeting 27 - 30 October 2025	New
18/12/2025	Medicine: Caelyx pegylated liposomal doxorubicin	Updated
18/12/2025	Medicine: Azacitidine Kabi azacitidine	Updated
18/12/2025	Shortage: Fiasp PumpCart (insulin aspart) insulin aspart	Updated
18/12/2025	Document: Name Review Group form - questions and answers	Updated
18/12/2025	Shortage: NovoRapid PumpCart (insulin aspart) insulin aspart	Updated
18/12/2025	Medicine: Breyanzi lisocabtagene maraleucel	Updated
18/12/2025	Page: Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline	Updated
18/12/2025	Medicine: Alyftrek deutivacaftor / tezacaftor / vanzacaftor	Updated
18/12/2025	Medicine: Invokana canagliflozin	Updated
18/12/2025	PIP: EMA/PE/0000232894 - paediatric investigation plan adeno-associated viral vector serotype 9 containing the human MECP2 gene (TSHA-102)	New
18/12/2025	PIP: EMA/PE/0000232896 - paediatric investigation plan antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to N-acetylgalactosamine (AZD2693), sodium salt	New
18/12/2025	Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 November 2025	New
18/12/2025	Event: EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation	Updated
17/12/2025	Medicine: Ziihera zanidatamab	Updated
17/12/2025	Medicine: Trumenba meningococcal group b vaccine (recombinant, adsorbed)	Updated
17/12/2025	Medicine: Lucentis ranibizumab	Updated
17/12/2025	Medicine: Entyvio vedolizumab	Updated
17/12/2025	Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)	Updated
17/12/2025	Page: Medicine shortages and availability issues: guidance for companies	Updated
17/12/2025	Document: Call for user acceptance testers for the read functionality in the Public Product Management Service (PMS) Application Programming Interface (API)	Updated
17/12/2025	Document: Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP) pilot report	New
17/12/2025	Document: Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals	Updated
17/12/2025	Medicine: Ocrevus ocrelizumab	Updated
17/12/2025	Event: Quarterly System Demo - Q4 2025	Updated
17/12/2025	Document: Overview of (invented) names reviewed in November 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 11 December 2025	New
17/12/2025	Medicine: Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)	Updated
17/12/2025	PIP: EMA/PE/0000182345 - paediatric investigation plan inbakicept, nogapendekin alfa	New
17/12/2025	PIP: EMA/PE/0000182333 - paediatric investigation plan precemtabart tocentecan	New
17/12/2025	PIP: EMA/PE/0000182297 - paediatric investigation plan oxybutynin	New
17/12/2025	PIP: EMA/PE/0000182239 - paediatric investigation plan setmelanotide	Updated
17/12/2025	PIP: EMA/PE/0000182217 - paediatric investigation plan cedazuridine; decitabine	Updated
17/12/2025	PIP: EMA/PE/0000182170 - paediatric investigation plan regorafenib	Updated
17/12/2025	Medicine: Tasigna nilotinib	Updated
17/12/2025	PIP: EMA/PE/0000181778 - paediatric investigation plan rilvegostomig	New
17/12/2025	Medicine: Rapiscan regadenoson	Updated
17/12/2025	PIP: EMA/PE/0000181518 - paediatric investigation plan Lerodalcibep	Updated
17/12/2025	PIP: EMA/PE/0000181441 - paediatric investigation plan telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy- 8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2- b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide	New
17/12/2025	PIP: EMA/PE/0000221101 - paediatric investigation plan esepapogene zalarnarepvec	New
17/12/2025	PIP: EMA/PE/0000181335 - paediatric investigation plan Budesonide; Formoterol (fumarate); glycopyrronium bromide	Updated
17/12/2025	PIP: EMA/PE/0000220986 - paediatric investigation plan tenapanor	New
17/12/2025	Referral: Oxbryta - referral voxelotor	Updated
17/12/2025	Medicine: Datroway datopotamab deruxtecan	Updated
17/12/2025	Event: Meeting on the impact of chemical and environmental policies on the healthcare sector and availability of medicines	New
17/12/2025	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
17/12/2025	Document: QRD Appendix V - Adverse-drug-reaction reporting details	Updated
17/12/2025	Medicine: Rivaroxaban Koanaa rivaroxaban	Updated
17/12/2025	PIP: EMA/PE/0000221175 - paediatric investigation plan vibegron	Updated
17/12/2025	PIP: EMA/PE/0000181300 - paediatric investigation plan avalglucosidase alfa	Updated
17/12/2025	PIP: EMA/PE/0000181294 - paediatric investigation plan Tolebrutinib	Updated
17/12/2025	PIP: EMA/PE/0000181238 - paediatric investigation plan resiquimod	New
17/12/2025	PIP: EMA/PE/0000181236 - paediatric investigation plan telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy- 8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2- b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide	New
17/12/2025	PIP: EMA/PE/0000221419 - paediatric investigation plan pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 8 – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 15C – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 6A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 15A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 16F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 19A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 23A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 24F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 17F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114]); pneumococcal polysaccharide serotype 10A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 12F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 20A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 31 – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 35B – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 7F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 22F – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 9N – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 11A – diphtheria CRM197 conjugate; pneumococcal polysaccharide serotype 23B – diphtheria CRM197 conjugate (V116)	Updated
17/12/2025	PIP: EMA/PE/0000181219 - paediatric investigation plan bedaquiline fumarate	Updated
17/12/2025	Page: Extended EudraVigilance medicinal product dictionary (XEVMPD) training	Updated
17/12/2025	Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - June 2026	New
17/12/2025	Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - March 2026	New
17/12/2025	Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - April 2026	New
17/12/2025	Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - March 2026	New
17/12/2025	Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - April 2026	New
16/12/2025	Document: Factsheet - Industry reporting via the European Shortages Monitoring Platform (ESMP) during a crisis or MSSG-led preparedness action	New
16/12/2025	Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)	Updated
16/12/2025	Medicine: Pradaxa dabigatran etexilate	Updated
16/12/2025	Medicine: Ngenla somatrogon	Updated
16/12/2025	Medicine: Matever levetiracetam	Updated
16/12/2025	Medicine: Seffalair Spiromax salmeterol; fluticasone propionate	Updated
16/12/2025	Medicine: Omforro midazolam	Updated
16/12/2025	Page: European Shortages Monitoring Platform (ESMP): Interoperability with national and pharmaceutical industry systems	New
16/12/2025	Page: European Shortages Monitoring Platform (ESMP)	Updated
16/12/2025	Medicine: Erelzi etanercept	Updated
16/12/2025	Document: Quality Review of Documents (QRD) working group plenary meeting dates	Updated
16/12/2025	Page: European Shortages Monitoring Platform (ESMP): Guidance, training materials and events	New
16/12/2025	Document: European Shortages Monitoring Platform (ESMP) Informational brief	Updated
16/12/2025	Document: Factsheet - Network reporting via the European Shortages Monitoring Platform (ESMP) during a crisis	New
16/12/2025	Document: Factsheet - Network reporting via the European Shortages Monitoring Platform (ESMP) during an MSSG-led preparedness action	New
16/12/2025	Document: Factsheet - Industry reporting via the European Shortages Monitoring Platform (ESMP) in normal circumstances	New
16/12/2025	Medicine: Kesimpta ofatumumab	Updated
16/12/2025	Medicine: Sunlenca lenacapavir	Updated
16/12/2025	Medicine: Ventavis iloprost	Updated
16/12/2025	Event: Q&A Clinic - New Variation Classification in eAF	New
16/12/2025	Medicine: Cyanokit hydroxocobalamin	Updated
16/12/2025	Medicine: Opsumit macitentan	Updated
16/12/2025	Medicine: Trisenox arsenic trioxide	Updated
16/12/2025	Medicine: Ambrisentan Viatris (previously Ambrisentan Mylan) ambrisentan	Updated
16/12/2025	Medicine: Cholib fenofibrate; simvastatin	Updated
16/12/2025	PIP: EMA/PE/0000221199 - paediatric investigation plan bemcentinib	New
16/12/2025	PIP: EMA/PE/0000221500 - paediatric investigation plan phleum pratense pollen extract	New
16/12/2025	PIP: EMA/PE/0000221511 - paediatric investigation plan recombinant human apolipoprotein A-I	New
16/12/2025	PIP: EMA/PE/0000221664 - paediatric investigation plan parietaria judaica pollen extract	New
16/12/2025	PIP: EMA/PE/0000221674 - paediatric investigation plan xaluritamig	New
16/12/2025	PIP: EMA/PE/0000221695 - paediatric investigation plan cupressus arizonica pollen extract	New
16/12/2025	PIP: EMA/PE/0000221772 - paediatric investigation plan olea europaea pollen extract	New
16/12/2025	PIP: EMA/PE/0000221424 - paediatric investigation plan dermatophagoides pteronyssinus extract	New
16/12/2025	Medicine: Libmeldy autologous CD34+ cells encoding ARSA gene	Updated
16/12/2025	Document: Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (14 November - 11 December 2025)	New
16/12/2025	Document: Start of procedure: Extension of marketing authorisation (14 November - 11 December 2025)	New
16/12/2025	Medicine: Agamree vamorolone	Updated
16/12/2025	Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025	Updated
16/12/2025	Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC	Updated
16/12/2025	Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC	Updated
15/12/2025	Medicine: Retsevmo selpercatinib	Updated
15/12/2025	Medicine: Coagadex human coagulation factor X	Updated
15/12/2025	Medicine: Remicade infliximab	Updated
15/12/2025	Page: Worksharing: questions and answers	Updated
15/12/2025	Page: Type-II variations: questions and answers	Updated
15/12/2025	Page: Extensions of marketing authorisations: questions and answers	Updated
15/12/2025	Medicine: Repatha evolocumab	Updated
15/12/2025	Medicine: Levetiracetam Hospira levetiracetam	Updated
15/12/2025	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
15/12/2025	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure	Updated
15/12/2025	Page: Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group	Updated
15/12/2025	Page: Podcast: Inside EMA	Updated
15/12/2025	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
15/12/2025	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure	Updated
15/12/2025	Page: Pre-authorisation guidance	Updated
12/12/2025	Document: Minutes of the CVMP meeting 4-6 November 2025	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Antimicrobials Working Party (AWP) 2026	New
12/12/2025	Event: HMA/EMA multi-stakeholder workshop on artificial intelligence (AI)	Updated
12/12/2025	Document: CTIS Simplification Task Force: topics for analysis	Updated
12/12/2025	Event: Clinical Trials Information System (CTIS) sponsor end user training programme - March 2026	New
12/12/2025	Event: 15th Industry Standing Group (ISG) meeting	Updated
12/12/2025	Document: Biomarkers in oncology indications approved in the EU: key facts	New
12/12/2025	Event: EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU	New
12/12/2025	Medicine: Clopidogrel Viatris (previously Clopidogrel Taw Pharma) clopidogrel	Updated
12/12/2025	Medicine: Prialt ziconotide	Updated
12/12/2025	Medicine: Synagis palivizumab	Updated
12/12/2025	Medicine: Azacitidine Mylan azacitidine	Updated
12/12/2025	Medicine: Libmyris adalimumab	Updated
12/12/2025	Medicine: Imaavy nipocalimab	Updated
12/12/2025	News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025	New
12/12/2025	News: New medicine to treat non-muscle invasive bladder cancer	New
12/12/2025	Medicine: Ranluspec ranibizumab	New
12/12/2025	Medicine: Gotenfia golimumab	New
12/12/2025	Medicine: Exdensur depemokimab	New
12/12/2025	Medicine: Jelrix autologous cartilage-derived articular chondrocytes, in-vitro expanded	Updated
12/12/2025	Medicine: Aumseqa Aumolertinib	New
12/12/2025	Medicine: mNexspike COVID-19 mRNA vaccine	New
12/12/2025	Medicine: Myqorzo aficamten	New
12/12/2025	Medicine: Anktiva nogapendekin alfa inbakicept	New
12/12/2025	Referral: Melatomed and associated names - referral melatonin	New
12/12/2025	Post-authorisation: Dovprela (previously Pretomanid FGK) - opinion on variation to marketing authorisation pretomanid	New
12/12/2025	Post-authorisation: Elucirem - opinion on variation to marketing authorisation gadopiclenol	New
12/12/2025	Post-authorisation: Vueway - opinion on variation to marketing authorisation gadopiclenol	New
12/12/2025	Post-authorisation: Nucala - opinion on variation to marketing authorisation mepolizumab	New
12/12/2025	Post-authorisation: Uplizna - opinion on variation to marketing authorisation inebilizumab	New
12/12/2025	Post-authorisation: Mounjaro - opinion on variation to marketing authorisation tirzepatide	New
12/12/2025	Post-authorisation: Eylea - opinion on variation to marketing authorisation aflibercept	New
12/12/2025	Post-authorisation: Winrevair - opinion on variation to marketing authorisation sotatercept	New
12/12/2025	Post-authorisation: Arexvy - opinion on variation to marketing authorisation recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E	New
12/12/2025	Post-authorisation: Vfend - opinion on variation to marketing authorisation voriconazole	New
12/12/2025	Post-authorisation: Simponi - opinion on variation to marketing authorisation golimumab	New
12/12/2025	Post-authorisation: Recarbrio - opinion on variation to marketing authorisation imipenem; cilastatin; relebactam	New
12/12/2025	Post-authorisation: Aspaveli - opinion on variation to marketing authorisation pegcetacoplan	New
12/12/2025	Medicine: Prevymis letermovir	Updated
12/12/2025	Event: Fourth European Medicines Agency - Medtech Europe bilateral meeting	Updated
12/12/2025	Page: Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline	Updated
12/12/2025	Document: Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2	New
12/12/2025	Document: Checklist for the submission of day +5 translations for a post-opinion linguistic review - veterinary	Updated
12/12/2025	Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-19 November 2025	New
12/12/2025	Page: Union list of critical medicines	Updated
12/12/2025	Document: Questions and answers on the Union list of critical medicines	Updated
12/12/2025	Document: Union list of critical medicines	New
12/12/2025	Page: ICH E22 General considerations for patient preference studies - Scientific guideline	New
12/12/2025	Document: ICH E22 Guideline on general considerations for patient preference studies - Step 2b	New
12/12/2025	Document: CVMP work plan 2026	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Efficacy Working Party (EWP-V) 2026	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2026	New
12/12/2025	Document: Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2026	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Pharmacovigilance Working Party (PhVWP-V) 2026	New
12/12/2025	Document: Work plan for the European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG) 2026	New
12/12/2025	Document: Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)	Updated
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Safety Working Party (SWP-V) 2025	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Immunologicals Working Party (IWP) 2026	New
12/12/2025	Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2026	New
12/12/2025	Page: Stability testing for applications for variations to marketing authorisation - Scientific guideline	Updated
12/12/2025	Document: Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3	New
11/12/2025	Medicine: Teriflunomide Viatris (previously Teriflunomide Mylan) teriflunomide	Updated
11/12/2025	Medicine: Darunavir Viatris (previously Darunavir Mylan) darunavir	Updated
11/12/2025	Medicine: Tobi Podhaler tobramycin	Updated
11/12/2025	Medicine: Afstyla lonoctocog alfa	Updated
11/12/2025	Document: Highlights - 20th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation meeting	New
11/12/2025	Event: New variations guidelines: webinar for marketing authorisation holders (human)	New
11/12/2025	Medicine: Pifeltro doravirine	Updated
11/12/2025	Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - February 2026	New
11/12/2025	Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - May 2026	New
11/12/2025	Medicine: Veyvondi vonicog alfa	Updated
11/12/2025	Medicine: Hyrimoz adalimumab	Updated
11/12/2025	Medicine: Hefiya adalimumab	Updated
11/12/2025	News: EMA welcomes political agreement on new EU pharmaceutical legislation	New
11/12/2025	Medicine: Mounjaro tirzepatide	Updated
11/12/2025	Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)	Updated
11/12/2025	Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – December 2025	Updated
11/12/2025	Document: Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (17 December 2025)	New
11/12/2025	Document: From laboratory to patients: How the safety of medicines is ensured in the European Union	Updated
11/12/2025	Document: Methodology European Specialised Expert Community (ESEC): Members	Updated
11/12/2025	PSUSA: PSUSA/00000177/202501 - periodic safety update report single assessment amlodipine / atorvastatin	New
11/12/2025	Document: Methodology Working Party (MWP) interested parties meeting report, September 2025	New
11/12/2025	Event: First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection	Updated
11/12/2025	Document: Consolidated 3-year work plan for the Emergency Task Force (ETF)	Updated
11/12/2025	DHPC: Tranexamic acid - direct healthcare professional communication (DHPC) tranexamic acid	New
11/12/2025	Page: Questions and answers on post approval change management protocols - Scientific guideline	Updated
11/12/2025	Document: Questions and answers on post approval change management protocols (PACMP) - Revision 1	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
11/12/2025	Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting inthe EU: Hands-on training course using the EudraVigilance System	New
10/12/2025	Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers	Updated
10/12/2025	Page: How to submit information on authorised and investigational medicines	Updated
10/12/2025	Document: Draft user manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)	New
10/12/2025	PIP: EMA/PE/0000183758 - paediatric investigation plan zimislecel	New
10/12/2025	PIP: EMA/PE/0000183430 - paediatric investigation plan tralokinumab	Updated
10/12/2025	PIP: EMA/PE/0000183866 - paediatric investigation plan brexpiprazole	Updated
10/12/2025	PIP: EMA/PE/0000184400 - paediatric investigation plan dapagliflozin; eplerenone	New
10/12/2025	PIP: EMA/PE/0000183220 - paediatric investigation plan iclepertin	Updated
10/12/2025	PIP: EMEA-002944-PIP01-20 - paediatric investigation plan 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1) (PF-06882961)	Updated
10/12/2025	PIP: EMEA-003104-PIP02-22 - paediatric investigation plan Favezelimab; pembrolizumab	Updated
10/12/2025	PIP: EMEA-002979-PIP01-21 - paediatric investigation plan pamrevlumab	Updated
10/12/2025	PIP: EMEA-001613-PIP04-21 - paediatric investigation plan tezepelumab	Updated
10/12/2025	PIP: EMEA-001758-PIP01-15-M02 - paediatric investigation plan Lumicitabine	Updated
10/12/2025	Medicine: Aimovig erenumab	Updated
10/12/2025	Medicine: Livogiva teriparatide	Updated
10/12/2025	Medicine: Kovaltry octocog alfa	Updated
10/12/2025	Medicine: Eydenzelt aflibercept	Updated
10/12/2025	Page: Radiopharmaceuticals - Scientific guideline	Updated
10/12/2025	Document: Draft guideline on quality of radiopharmaceuticals - Revision 2	New
10/12/2025	Event: 20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance	Updated
10/12/2025	Event: Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025	Updated
10/12/2025	Medicine: Sirolimus TriviumVet sirolimus	New
10/12/2025	Document: EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)	Updated
10/12/2025	Event: 2025 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)	New
10/12/2025	Document: Minutes of the CAT meeting 8-9 October 2025	New
10/12/2025	Document: Minutes of the CAT meeting 10-12 September 2025	New
10/12/2025	Page: Union Product Database	Updated
10/12/2025	Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) pandemic influenza vaccine (H5N1) (live attenuated, nasal)	Updated
10/12/2025	Medicine: Rizmoic naldemedine	Updated
10/12/2025	Medicine: Libtayo cemiplimab	Updated
10/12/2025	Document: Article 57 product data	Updated
10/12/2025	Medicine: Esbriet pirfenidone	Updated
10/12/2025	Medicine: Cejemly sugemalimab	Updated
10/12/2025	Page: Medical devices	Updated
10/12/2025	Page: List of medicines under additional monitoring	Updated
10/12/2025	Document: List of medicinal products under additional monitoring	Updated
10/12/2025	Document: List of medicinal products under additional monitoring	Updated
09/12/2025	Page: Dextrans - Scientific guideline	Updated
09/12/2025	PIP: EMA/PE/0000182447 - paediatric investigation plan amlitelimab	Updated
09/12/2025	PIP: EMA/PE/0000183373 - paediatric investigation plan tadalafil; tamsulosin	New
09/12/2025	PIP: EMA/PE/0000183329 - paediatric investigation plan interleukin-23 receptor antagonist peptide	Updated
09/12/2025	PIP: EMA/PE/0000183137 - paediatric investigation plan encaleret	Updated
09/12/2025	PIP: EMA/PE/0000182808 - paediatric investigation plan zoliflodacin	Updated
09/12/2025	PIP: EMA/PE/0000183083 - paediatric investigation plan (S)-(4-amino-1,3-dihydrofuro[3,4-c][1,7]naphthyridin-8-yl)(3-(4-(trifluoromethyl)phenyl)morpholino)methanone	New
09/12/2025	PIP: EMA/PE/0000182525 - paediatric investigation plan modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/ mRNA-4157)	New
09/12/2025	PIP: EMA/PE/0000182462 - paediatric investigation plan bizalimogene ralaplasmid; mavilimogene ralaplasmid; rocakinogene sifuplasmid	New
09/12/2025	PIP: EMA/PE/0000182440 - paediatric investigation plan resiniferatoxin	New
09/12/2025	Medicine: Carbaglu carglumic acid	Updated
09/12/2025	Page: Cancer Medicines Forum	Updated
09/12/2025	Document: Mandate, objectives and rules of procedure for the Cancer Medicines Forum	New
09/12/2025	Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)	Updated
09/12/2025	Document: Bimervax: Periodic safety update report assessment 30 September 2024 - 29 March 2025	New
09/12/2025	Medicine: Enzalutamide Viatris enzalutamide	Updated
09/12/2025	Document: Concept paper on the guideline revision on good pharmacogenomic practice	Updated
09/12/2025	Medicine: Loargys pegzilarginase	Updated
09/12/2025	Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025	Updated
09/12/2025	Document: Meeting summary - PCWP/HCPWP and all eligible organisations meeting 18 November 2025	New
09/12/2025	Medicine: Inbrija levodopa	Updated
09/12/2025	Medicine: Anzupgo delgocitinib	Updated
09/12/2025	Medicine: Gohibic vilobelimab	Updated
09/12/2025	Document: List of substances and products subject to worksharing for signal management	Updated
09/12/2025	Page: Combination Products Operational Group	Updated
09/12/2025	Document: Combination Products Operational Group (COMBO) - Terms of reference	New
09/12/2025	Medicine: Kimmtrak tebentafusp	Updated
09/12/2025	Medicine: Opdivo nivolumab	Updated
09/12/2025	Medicine: Levetiracetam Accord levetiracetam	Updated
09/12/2025	Medicine: Dacogen decitabine	Updated
09/12/2025	Document: Consolidated 3-year rolling work plan for the Methodology Working Party 2026-2028	New
09/12/2025	News: New data on antimicrobials sales and use in animals in the EU	New
09/12/2025	Page: European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance reports	Updated
09/12/2025	Document: European sales and use of antimicrobials for veterinary medicine: Annual surveillance report for 2024	New
09/12/2025	Document: 3-year work plan for the joint CHMP/CVMP Quality Working Party 2026-2028	New
09/12/2025	Document: Consolidated 3-year rolling work plan for the Non-clinical domain 2026-2028	New
09/12/2025	Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party	Updated
09/12/2025	Page: Questions and answers for biological medicinal products	Updated
09/12/2025	Document: New Approach Methodologies EU-IN Horizon Scanning Report	Updated
09/12/2025	Document: 3-year rolling work plan for the Biosimilar Medicinal Products Working Party 2026-2028	New
09/12/2025	Document: Alzheimer’s disease EU-IN Horizon Scanning Report	Updated
09/12/2025	Document: 3-year work plan for the Biologics Working Party (BWP) 2026-2028	New
09/12/2025	Medicine: Aubagio teriflunomide	Updated
09/12/2025	Page: Development and manufacture of synthetic peptides - Scientific guideline	Updated
09/12/2025	Document: Guideline on the development and manufacture of synthetic peptides	New
09/12/2025	Event: 15th industry stakeholder platform on research and development support	Updated
09/12/2025	Medicine: Eviplera emtricitabine; rilpivirine; tenofovir disoproxil	Updated
09/12/2025	Medicine: Abecma idecabtagene vicleucel	Updated
09/12/2025	Medicine: Kostaive zapomeran	Updated
09/12/2025	PIP: EMEA-003580-PIP01-24 - paediatric investigation plan 6'-([(1S,3S)-3-([5-(difluoromethoxy)-2- pyrimidinyl]amino)cyclopentyl]amino)-2H- [1,3'-bipyridin]-2-one (AZD0780)	New
09/12/2025	PIP: EMEA-003564-PIP01-23 - paediatric investigation plan olorofim	New
09/12/2025	PIP: EMEA-003558-PIP01-23 - paediatric investigation plan linaprazan glurate	New
09/12/2025	PIP: EMEA-003588-PIP01-24 - paediatric investigation plan 7-ethyl-10-hydroxy-camptothecin	New
09/12/2025	PIP: EMEA-003592-PIP01-24 - paediatric investigation plan gorilla adenovirus vector expressing HPV6 and HPV11 antigens (PRGN-2012)	New
09/12/2025	PIP: EMEA-003614-PIP01-24 - paediatric investigation plan diazoxide choline	New
09/12/2025	Page: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): 2009 - 2023	Updated
08/12/2025	Document: Agenda - PDCO agenda of the 9-12 December 2025 meeting	New
08/12/2025	PIP: EMEA-003556-PIP02-24 - paediatric investigation plan tulisokibart	New
08/12/2025	PIP: EMEA-003556-PIP01-23 - paediatric investigation plan tulisokibart	New
08/12/2025	PIP: EMEA-003506-PIP01-23 - paediatric investigation plan doruxapapogenum ralaplasmidum	New
08/12/2025	PIP: EMEA-002978-PIP02-24 - paediatric investigation plan trastuzumab deruxtecan	New
08/12/2025	Herbal: Carvi fructus - herbal medicinal product Caraway fruit	Updated
08/12/2025	Herbal: Carvi aetheroleum - herbal medicinal product Caraway oil	Updated
08/12/2025	PIP: EMA/PE/0000225184 - paediatric investigation plan nirmatrelvir; ritonavir	Updated
08/12/2025	Herbal: Althaeae radix - herbal medicinal product Marshmallow Root	Updated
08/12/2025	Medicine: Palforzia defatted powder of Arachis hypogaea L., semen (peanuts)	Updated
08/12/2025	Medicine: Tecartus brexucabtagene autoleucel	Updated
08/12/2025	Medicine: Yescarta axicabtagene ciloleucel	Updated
08/12/2025	Medicine: Caprelsa vandetanib	Updated
08/12/2025	Document: Medicine shortage communication (MSC): Insulin lispro Sanofi (insulin lispro 100 units/ml solution for injection in cartridge and pre-filled pen)	New
08/12/2025	Shortage: Insulin lispro Sanofi insulin lispro	New
08/12/2025	Medicine: Neulasta pegfilgrastim	Updated
08/12/2025	Medicine: Zubsolv buprenorphine; naloxone	Updated
08/12/2025	Medicine: Symkevi tezacaftor; ivacaftor	Updated
08/12/2025	Document: Programme - Joint HMA/EMA multi-stakeholder workshop on Patient Registries December 2025	Updated
08/12/2025	Document: Medicinal products for human use: monthly figures - November 2025	New
08/12/2025	Medicine: Xermelo telotristat ethyl	Updated
08/12/2025	Medicine: Scemblix asciminib	Updated
08/12/2025	Document: Agenda - HMA/EMA Annual Data Forum 2025	Updated
08/12/2025	Medicine: Filspari sparsentan	Updated
08/12/2025	Event: Committee for Medicinal Products for Human Use (CHMP): 08-11 December 2025	Updated
08/12/2025	Document: Annex to agenda of the CHMP meeting 8-11 December 2025	New
08/12/2025	Document: Agenda of the CHMP meeting 8-11 December 2025	New
08/12/2025	Document: Classification of changes (tracked changes)	Updated
08/12/2025	Document: Classification of changes	Updated
08/12/2025	Event: EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures	Updated
08/12/2025	Page: Union Product Database: release notes	Updated
08/12/2025	Document: Release notes - production release version 1.7.2544 - 5 December 2025 - Veterinary Medicinal Products Regulation: Union Product Database	New
08/12/2025	Medicine: Ebglyss lebrikizumab	Updated
08/12/2025	Medicine: Lyfnua gefapixant	Updated
08/12/2025	Medicine: Eucreas vildagliptin; metformin	Updated
08/12/2025	PIP: EMA/PE/0000224486 - paediatric investigation plan amlodipine; ramipril; rosuvastatin	New
08/12/2025	PIP: EMA/PE/0000224202 - paediatric investigation plan Dengue tetravalent vaccine (live, attenuated)	Updated
08/12/2025	PIP: EMA/PE/0000221803 - paediatric investigation plan betula pendula pollen extract	New
08/12/2025	Document: Product Management Service (PMS) roadmap	Updated
08/12/2025	Page: Scientific publications	Updated
08/12/2025	Event: EMA/HMA annual data forum	Updated
08/12/2025	Page: Good pharmacogenomic practice - Scientific guideline	Updated
08/12/2025	Page: Substance and product data management services	Updated
08/12/2025	DHPC: Remsima - direct healthcare professional communication (DHPC) infliximab	New
05/12/2025	Medicine: Ravicti glycerol phenylbutyrate	Updated
05/12/2025	Medicine: Adynovi rurioctocog alfa pegol	Updated
05/12/2025	Medicine: Icandra (previously Vildagliptin / metformin hydrochloride Novartis) vildagliptin; metformin	Updated
05/12/2025	Medicine: Zomarist vildagliptin; metformin	Updated
05/12/2025	Medicine: Voraxaze glucarpidase	Updated
05/12/2025	News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 2-4 December 2025	New
05/12/2025	Medicine: Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A. Epizootic haemorrhagic disease vaccine (recombinant protein)	New
05/12/2025	Medicine: Firocoxib CP-Pharma firocoxib	New
05/12/2025	Medicine: Varenzin molidustat	New
05/12/2025	Post-authorisation: Dexdomitor - opinion on variation to marketing authorisation dexmedetomidine	New
05/12/2025	Medicine: Imnovid (previously Pomalidomide Celgene) pomalidomide	Updated
05/12/2025	Page: Medicines for human use under evaluation	Updated
05/12/2025	Document: Applications for new human medicines under evaluation: December 2025	New
05/12/2025	Page: Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'	Updated
05/12/2025	Document: All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5	New
05/12/2025	PIP: EMA/PE/0000183059 - paediatric investigation plan abrocitinib	Updated
05/12/2025	PIP: EMA/PE/0000221076 - paediatric investigation plan adrenaline (epinephrine)	Updated
05/12/2025	PIP: EMA/PE/0000221589 - paediatric investigation plan split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain; split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain; split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage); split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Updated
05/12/2025	PIP: EMA/PE/0000238005 - paediatric investigation plan inebilizumab	Updated
05/12/2025	PIP: EMA/PE/0000238074 - paediatric investigation plan Mitapivat	Updated
05/12/2025	PIP: EMA/PE/0000182362 - paediatric investigation plan tildrakizumab	Updated
05/12/2025	PIP: EMA/PE/0000221709 - paediatric investigation plan apitegromab	Updated
05/12/2025	PIP: EMA/PE/0000254020 - paediatric investigation plan risankizumab	Updated
05/12/2025	PIP: EMA/PE/0000274326 - paediatric investigation plan risankizumab	Updated
04/12/2025	Page: Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU - Scientific guideline	Updated
04/12/2025	Document: Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU	New
04/12/2025	Medicine: Denosumab Intas denosumab	Updated
04/12/2025	Page: CHMP opinions on consultation procedures	Updated
04/12/2025	Document: Consultation on an ancillary medicinal substance incorporated in a medical device - Gynemed GmbH & Co. KG HSA-containing ART media	New
04/12/2025	Document: Consideration on core requirements for RMPs of COVID-19 vaccines	Updated
04/12/2025	Medicine: Jivi damoctocog alfa pegol	Updated
04/12/2025	Medicine: Sogroya somapacitan	Updated
04/12/2025	Page: Availability of medicines before and during crises	Updated
04/12/2025	Medicine: Nucala mepolizumab	Updated
04/12/2025	Medicine: Dengvaxia dengue tetravalent vaccine (live, attenuated)	Updated
04/12/2025	Shortage: Dynastat parecoxib	Updated
04/12/2025	Medicine: Paxlovid nirmatrelvir; ritonavir	Updated
04/12/2025	Page: Antiviral medicines for pandemic influenza	Updated
04/12/2025	Page: Signal management (veterinary medicines)	Updated
04/12/2025	Page: Veterinary good pharmacovigilance practices (VGVP)	Updated
04/12/2025	Document: Veterinary Union Pharmacovigilance Database - Best Practice Guide	Updated
04/12/2025	Document: Veterinary signal assessment report for marketing authorisation holders	Updated
04/12/2025	Medicine: Brinsupri Brensocatib	Updated
04/12/2025	Medicine: Tuzodi midazolam	Updated
04/12/2025	Medicine: Hetlioz tasimelteon	Updated
04/12/2025	Medicine: Adcetris brentuximab vedotin	Updated
04/12/2025	Document: Veterinary Scientific Advice procedure – timelines 2026 - information for applicants	Updated
04/12/2025	Medicine: Lynparza olaparib	Updated
04/12/2025	Medicine: Sunitinib Accord sunitinib	Updated
04/12/2025	Document: Dengvaxia : EPAR - All authorised presentations	Updated
04/12/2025	Medicine: Tagrisso osimertinib	Updated
04/12/2025	Page: Website outages and upgrades	Updated
03/12/2025	Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - November 2025	Updated
03/12/2025	Medicine: Tryngolza olezarsen	Updated
03/12/2025	Page: Eligible healthcare professionals' organisations	Updated
03/12/2025	Document: Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities	Updated
03/12/2025	Medicine: Baraclude entecavir	Updated
03/12/2025	PSUSA: PSUSA/00000576/202412 - periodic safety update report single assessment caspofungin	New
03/12/2025	PSUSA: PSUSA/00002947/202412 - periodic safety update report single assessment tibolone	New
03/12/2025	Medicine: Delstrigo doravirine; lamivudine; tenofovir disoproxil	Updated
03/12/2025	Medicine: Cancidas (previously Caspofungin MSD) caspofungin	Updated
03/12/2025	Medicine: Incellipan pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)	Updated
03/12/2025	Medicine: NexoBrid concentrate of proteolytic enzymes enriched in bromelain	Updated
03/12/2025	Medicine: Enhertu trastuzumab deruxtecan	Updated
03/12/2025	Medicine: Adempas riociguat	Updated
03/12/2025	Page: EudraVigilance: electronic reporting	Updated
03/12/2025	Document: Compliance notifications explanation and Q&A	New
03/12/2025	Medicine: Keytruda pembrolizumab	Updated
03/12/2025	Document: HMPC: overview of assessment work - priority list	Updated
03/12/2025	Document: EMA decision on adoption by analogy of Commission decision C (2025) 2495	New
03/12/2025	Medicine: Protopic tacrolimus	Updated
03/12/2025	Medicine: Oczyesa octreotide	Updated
03/12/2025	Page: Safety of medicines	Updated
03/12/2025	Document: Keeping medicines safe: Reporting side effects can make medicines safer for everyone	New
03/12/2025	Document: Keeping medicines safe: What actions can EMA take?	New
03/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - April 2026	New
03/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026	New
03/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - January 2026	New
03/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - March 2026	New
03/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - May 2026	New
03/12/2025	Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - February 2026	New
03/12/2025	Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - January 2026	New
03/12/2025	Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2026	New
03/12/2025	Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2026	New
03/12/2025	Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2026	New
03/12/2025	Page: Network Data Steering Group (NDSG)	Updated
03/12/2025	Document: HMA-EMA joint Network Data Steering Group meeting - 6 October 2025	New
03/12/2025	Medicine: Ontozry cenobamate	Updated
03/12/2025	Medicine: Aybintio bevacizumab	Updated
03/12/2025	Document: Agenda of the CAT meeting 3-5 December 2025	New
02/12/2025	PSUSA: PSUSA/00002558/202501 - periodic safety update report single assessment propylthiouracil	New
02/12/2025	Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service	Updated
02/12/2025	Document: CAT quarterly highlights and approved ATMPs - December 2025	New
02/12/2025	EU-M4all: Aluvia - opinion on medicine for use outside EU lopinavir; ritonavir	Updated
02/12/2025	Page: Outcomes of imposed non-interventional post-authorisation safety studies	Updated
02/12/2025	Medicine: Kaletra lopinavir; ritonavir	Updated
02/12/2025	Medicine: Pregabalin Sandoz pregabalin	Updated
02/12/2025	Medicine: Izamby denosumab	Updated
02/12/2025	Medicine: Mysildecard sildenafil	Updated
02/12/2025	Medicine: Gilenya fingolimod	Updated
02/12/2025	Medicine: Tevimbra tislelizumab	Updated
02/12/2025	Medicine: Krazati adagrasib	Updated
02/12/2025	Medicine: Upstaza eladocagene exuparvovec	Updated
02/12/2025	PIP: EMEA-001451-PIP02-24 - paediatric investigation plan tildrakizumab	New
02/12/2025	PIP: EMEA-001943-PIP07-24 - paediatric investigation plan ravulizumab	New
02/12/2025	PIP: EMA/PE/0000232315 - paediatric investigation plan spesolimab	Updated
02/12/2025	Event: Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 December 2025	Updated
02/12/2025	Document: Agenda of the CVMP meeting 2-4 December 2025	New
02/12/2025	Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes	Updated
02/12/2025	Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)	Updated
02/12/2025	Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants	Updated
02/12/2025	Document: Union Product Database (UPD) - Questions & answers: Network use	New
02/12/2025	Document: Union Product Database (UPD) registration guide for UI and API users	Updated
02/12/2025	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - February 2026	New
02/12/2025	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - January 2026	New
02/12/2025	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - April 2026	New
02/12/2025	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - March 2026	New
02/12/2025	Event: Q&A clinic on Substance, Organisation, Referentials Management Services - May 2026	New
02/12/2025	Event: SPOR and XEVMPD status update webinar - Q2 2026	New
02/12/2025	Event: SPOR and XEVMPD status update webinar - Q3 2026	New
02/12/2025	Event: SPOR and XEVMPD status update webinar - Q4 2026	New
02/12/2025	Document: Agenda of the COMP meeting 2-3 December 2025	New
01/12/2025	PSUSA: PSUSA/00010883/202504 - periodic safety update report single assessment carvedilol / ivabradine	New
01/12/2025	PSUSA: PSUSA/00003097/202501 - periodic safety update report single assessment vancomycin	New
01/12/2025	Medicine: Xofluza baloxavir marboxil	Updated
01/12/2025	Medicine: Rasagiline Viatris (previously Rasagiline Mylan) rasagiline	Updated
01/12/2025	Medicine: Benepali etanercept	Updated
01/12/2025	Medicine: Xelevia sitagliptin	Updated
01/12/2025	Medicine: Cerezyme imiglucerase	Updated
01/12/2025	EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda - opinion on medicine for use outside EU dengue tetravalent vaccine (live, attenuated)	Updated
01/12/2025	Event: Third workshop between notified bodies and expert panels	New
01/12/2025	Medicine: Erleada apalutamide	Updated
01/12/2025	Medicine: Velmetia sitagliptin; metformin	Updated
01/12/2025	Medicine: Rivastigmine Sandoz rivastigmine	Updated
01/12/2025	Medicine: Rivastigmine Hexal rivastigmine	Updated
01/12/2025	Medicine: Rivastigmine 1 A Pharma rivastigmine	Updated
01/12/2025	Medicine: Zinplava bezlotoxumab	Updated
01/12/2025	Medicine: Efficib sitagliptin; metformin	Updated
01/12/2025	Medicine: Akynzeo netupitant; palonosetron	Updated
01/12/2025	Medicine: Briviact (in Italy: Nubriveo) brivaracetam	Updated
01/12/2025	Medicine: Tesavel sitagliptin	Updated
01/12/2025	Medicine: Dupixent dupilumab	Updated
01/12/2025	Page: Clinical investigation of medicinal products in the treatment of Parkinson's disease - Scientific guideline	Updated
01/12/2025	Document: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease	New
01/12/2025	Document: Minutes - Management Board meeting: 2 October 2025	New
01/12/2025	Document: Appendix 1: Acceptable intakes established for N-nitrosamines	Updated
01/12/2025	Page: Stakeholders and Communication	Updated

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