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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 (317)

Date	Content	Status
16/10/2026	Medicine: Stelara ustekinumab	Updated
16/10/2026	Medicine: Idelvion albutrepenonacog alfa	Updated
16/10/2026	Medicine: Remicade infliximab	Updated
16/10/2026	Medicine: Deferasirox Mylan deferasirox	Updated
16/10/2026	Medicine: Foundayo Orforglipron	New
16/10/2026	Medicine: Fovlussea ranibizumab	New
16/10/2026	Medicine: Yuviwel Navepegritide	New
16/10/2026	Medicine: Neuzafy filgrastim	New
16/10/2026	Medicine: Kizfizo temozolomide	New
16/10/2026	Medicine: Mylotarg gemtuzumab ozogamicin	Updated
16/10/2026	News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026	New
16/10/2026	News: New oral GLP-1 medicine for weight management and type 2 diabetes	New
16/10/2026	Post-authorisation: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) - opinion on variation to marketing authorisation pandemic influenza vaccine (H5N1) (live attenuated, nasal)	New
16/10/2026	Post-authorisation: Talvey - opinion on variation to marketing authorisation talquetamab	New
16/10/2026	Post-authorisation: Ibrance - withdrawal of application for variation to marketing authorisation palbociclib	New
16/10/2026	Post-authorisation: Kyinsu - opinion on variation to marketing authorisation insulin icodec; semaglutide	New
16/10/2026	Post-authorisation: Tukysa - opinion on variation to marketing authorisation tucatinib	New
16/10/2026	Document: Overview of (invented) names reviewed in September 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 15 October 2026	New
16/10/2026	Page: Cancer Medicines Pathfinder	Updated
16/10/2026	Medicine: Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence	Updated
16/10/2026	Page: Combination Products Operational Group: agendas and highlight reports	Updated
16/10/2026	Document: Agenda - Combination Products Operational Group (COMBO) - In vitro Diagnostics - 21 October 2026	New
16/10/2026	Document: Annex to 23-26 March 2026 CHMP minutes	New
16/10/2026	Document: Minutes of the CHMP meeting 23-26 March 2026	New
16/10/2026	Scientific guideline: Clinical investigation of immunosuppressants for solid organ transplantation - Scientific guideline	Updated
16/10/2026	Document: Concept paper on clinical trials in recipients of kidney transplantation	New
15/10/2026	Event: Seventeenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines	Updated
15/10/2026	Medicine: Optruma raloxifene	Updated
15/10/2026	PSUSA: PSUSA/00001694/202603 - periodic safety update report single assessment hydroxyethyl starch, hydroxyethyl starch combinations	New
15/10/2026	Referral: Rifadin oral suspension and syrup and associated names - referral rifampicin	Updated
15/10/2026	Medicine: Ratiograstim filgrastim	Updated
15/10/2026	Medicine: Tevagrastim filgrastim	Updated
15/10/2026	Medicine: Elaprase idursulfase	Updated
15/10/2026	Medicine: Mirvaso brimonidine	Updated
15/10/2026	Medicine: Rasonque Daraxonrasib	New
15/10/2026	News: EMA recommends authorisation of Rasonque for metastatic pancreatic cancer	New
15/10/2026	Event: EMA paediatric investigation plans in-person training course	New
15/10/2026	Medicine: Cabometyx cabozantinib	Updated
15/10/2026	Medicine: Nexviadyme avalglucosidase alfa	Updated
15/10/2026	Document: Draft reflection paper on the investigation of drug interactions of herbal medicinal products	New
15/10/2026	Medicine: Koselugo selumetinib	Updated
15/10/2026	Medicine: Opuviz aflibercept	Updated
15/10/2026	Page: Academia	Updated
14/10/2026	PIP: EMEA-002727-PIP03-23 - paediatric investigation plan nivolumab; relatlimab	Updated
14/10/2026	Medicine: Dovprela (previously Pretomanid FGK) pretomanid	Updated
14/10/2026	Medicine: Fymskina ustekinumab	Updated
14/10/2026	Medicine: Vyndaqel tafamidis	Updated
14/10/2026	Medicine: Welireg belzutifan	Updated
14/10/2026	Medicine: Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) tenofovir disoproxil	Updated
14/10/2026	Medicine: Poherdy pertuzumab	Updated
14/10/2026	Document: Outcome of written procedures finalised during the period from 04 June 2026 to 22 September 2026	New
14/10/2026	Medicine: Iasibon ibandronic acid	Updated
14/10/2026	PIP: EMA/PE/0000243861 - paediatric investigation plan venglustat	Updated
14/10/2026	PIP: EMA/PE/0000258095 - paediatric investigation plan levodopa; carbidopa monohydrate	New
14/10/2026	PIP: EMA/PE/0000244980 - paediatric investigation plan mirabegron; solifenacin	New
14/10/2026	PIP: EMA/PE/0000240600 - paediatric investigation plan mirabegron; solifenacin	New
14/10/2026	PIP: EMA/PE/0000243891 - paediatric investigation plan azacitidine; cedazuridine	New
14/10/2026	Medicine: Humira adalimumab	Updated
14/10/2026	PIP: EMA/PE/0000245064 - paediatric investigation plan avutometinib; defactinib	New
14/10/2026	Page: Women's health	Updated
14/10/2026	Medicine: Pritor telmisartan	Updated
14/10/2026	Event: Regulatory perspectives on herbal medicinal / botanical drug product development: Joint FDA / EMA workshop	Updated
14/10/2026	Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine	Updated
14/10/2026	Medicine: Nemluvio nemolizumab	Updated
14/10/2026	Medicine: mResvia respiratory syncytial virus mRNA vaccine	Updated
14/10/2026	Event: Meeting of the HMA-EMA group focused on AI with industry stakeholders - October 2026	New
14/10/2026	PIP: EMA/PE/0000245149 - paediatric investigation plan mifepristone; misoprostol	New
14/10/2026	PIP: EMA/PE/0000241632 - paediatric investigation plan linaprazan glurate	New
14/10/2026	PIP: EMA/PE/0000245628 - paediatric investigation plan ivonescimab	New
14/10/2026	PIP: EMA/PE/0000245862 - paediatric investigation plan ivonescimab	New
14/10/2026	PIP: EMA/PE/0000235505 - paediatric investigation plan tislelizumab	New
14/10/2026	PIP: EMA/PE/0000234649 - paediatric investigation plan pasritamig	New
14/10/2026	PIP: EMEA-003313-PIP02-23 - paediatric investigation plan povorcitinib	New
14/10/2026	PIP: EMA/PE/0000223258 - paediatric investigation plan afimkibart	New
14/10/2026	PIP: EMA/PE/0000223040 - paediatric investigation plan iloperidone	New
14/10/2026	PIP: EMA/PE/0000183462 - paediatric investigation plan autologous regulatory T lymphocytes CD3+ CD4+ CD25+ CD127- FoxP3+, ex-vivo expanded (PolTreg-T1D)	New
14/10/2026	Scientific guideline: Investigation of bioequivalence - Scientific guideline	Updated
14/10/2026	Medicine: Denosumab Ascend denosumab	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development: CHMP qualification opinions	New
13/10/2026	Page: Qualification of novel methodologies for medicine development: Letters of support	New
13/10/2026	Medicine: Revatio sildenafil	Updated
13/10/2026	Medicine: Lyrica pregabalin	Updated
13/10/2026	Medicine: Viagra sildenafil	Updated
13/10/2026	Medicine: Olumiant baricitinib	Updated
13/10/2026	Medicine: Jemperli dostarlimab	Updated
13/10/2026	Medicine: Fingolimod Accord fingolimod	Updated
13/10/2026	Medicine: Cometriq cabozantinib	Updated
13/10/2026	Medicine: Imfinzi durvalumab	Updated
13/10/2026	Medicine: Rinvoq upadacitinib	Updated
13/10/2026	EU-M4all: Mosquirix - opinion on medicine for use outside EU Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)	Updated
13/10/2026	Medicine: Bemfola follitropin alfa	Updated
13/10/2026	Document: Agenda - PDCO agenda of the 13-16 October 2026 meeting	New
13/10/2026	Medicine: Nexium Control esomeprazole	Updated
13/10/2026	Document: Business process description for medical devices	Updated
13/10/2026	Medicine: Intuniv guanfacine	Updated
13/10/2026	Document: Voluntary data submission (VDS) pilot application form	Updated
13/10/2026	Medicine: Qalsody tofersen	Updated
13/10/2026	Document: Article 57 product data	Updated
13/10/2026	Event: IncreaseNET and EU-Innovation Network 2026 Innovation & Competitiveness Summit: Strengthening Europe's Ecosystem	New
13/10/2026	Document: HMPC: overview of assessment work - priority list	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development (QoNM)	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development: High-level information on CHMP qualification advice	New
13/10/2026	Event: Risk management information day 2022	Updated
13/10/2026	Document: Appendix 1: Acceptable intakes established for N-nitrosamines	Updated
12/10/2026	Medicine: Casgevy exagamglogene autotemcel	Updated
12/10/2026	Medicine: Rhokiinsa netarsudil	Updated
12/10/2026	Medicine: Roclanda latanoprost / netarsudil	Updated
12/10/2026	Medicine: Duvyzat givinostat	Updated
12/10/2026	Medicine: Lazcluze lazertinib	Updated
12/10/2026	Medicine: Altuvoct efanesoctocog alfa	Updated
12/10/2026	Medicine: Ofev nintedanib	Updated
12/10/2026	Page: New Approach Methodologies Operational Expert Group	New
12/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2026	Updated
12/10/2026	Document: Annex to agenda of the CHMP meeting 12-15 October 2026	New
12/10/2026	Document: Agenda of the CHMP meeting 12-15 October 2026	New
12/10/2026	Medicine: Sunitinib Accord sunitinib	Updated
12/10/2026	Medicine: Daybu trofinetide	Updated
12/10/2026	Scientific guideline: Concept paper on the need for the guideline on the clinical investigation of medicinal products for the treatment of inherited retinal dystrophies - Scientific guideline	New
09/10/2026	Medicine: Etcamah camizestrant	Updated
09/10/2026	PIP: EMA/PE/0000183092 - paediatric investigation plan polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain (NNC0487-0111)	New
09/10/2026	PIP: EMA/PE/0000180736 - paediatric investigation plan brogidirsen	New
09/10/2026	Document: Medicinal products for human use: monthly figures - September 2026	New
09/10/2026	Document: Annual report of the Pharmacovigilance Inspectors Working Group for 2025	New
09/10/2026	Medicine: Pylclari piflufolastat (18F)	Updated
09/10/2026	Page: Paediatric investigation plans	Updated
09/10/2026	Page: Paediatric investigation plans: questions and answers	Updated
09/10/2026	Post-authorisation: Kalydeco - withdrawal of application for variation to marketing authorisation ivacaftor	Updated
09/10/2026	Document: Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards	Updated
09/10/2026	Document: European Medicines Agency policy on changes in scope of paediatric investigation plan (PIP) decisions	Updated
09/10/2026	DHPC: Ocrevus - direct healthcare professional communication (DHPC) ocrelizumab	New
09/10/2026	Medicine: Stemyca equine umbilical cord mesenchymal stem cells	New
09/10/2026	Medicine: Bovilis Lumpyvax Lumpy skin disease vaccine (live)	New
09/10/2026	News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 October 2026	New
09/10/2026	News: EMA recommends authorisation of veterinary vaccine for lumpy skin disease in cattle	New
09/10/2026	Medicine: Giapreza angiotensin II	Updated
09/10/2026	Event: 21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance	New
09/10/2026	Document: Decision of the Management Board amending budget No. 01, amending appropriations in budget 2026 and transfer of appropriations	New
09/10/2026	Document: Applications for new human medicines under evaluation: October 2026	New
09/10/2026	Medicine: Svariya (previously Rivaroxaban Koanaa) rivaroxaban	Updated
09/10/2026	Document: Agenda - European Medicines Agency workshop on bacteriophage therapy	Updated
09/10/2026	PIP: EMA/PE/0000245485 - paediatric investigation plan ustekinumab	Updated
09/10/2026	PIP: EMA/PE/0000247846 - paediatric investigation plan arimoclomol citrate	Updated
09/10/2026	PIP: EMA/PE/0000245644 - paediatric investigation plan navenibart	Updated
09/10/2026	PIP: EMA/PE/0000245980 - paediatric investigation plan sepofarsen	Updated
09/10/2026	PIP: EMA/PE/0000245997 - paediatric investigation plan ketamine; sufentanil	Updated
09/10/2026	PIP: EMA/PE/0000245698 - paediatric investigation plan tolebrutinib	Updated
09/10/2026	PIP: EMA/PE/0000245423 - paediatric investigation plan human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein	Updated
09/10/2026	PIP: EMA/PE/0000245173 - paediatric investigation plan iptacopan	Updated
09/10/2026	PIP: EMA/PE/0000246985 - paediatric investigation plan cedazuridine; decitabine	Updated
09/10/2026	PIP: EMA/PE/0000245146 - paediatric investigation plan Insulin lispro (BC222)	Updated
09/10/2026	PIP: EMA/PE/0000244420 - paediatric investigation plan vamorolone	Updated
09/10/2026	PIP: EMA/PE/0000242381 - paediatric investigation plan mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)	Updated
09/10/2026	PIP: EMA/PE/0000227737 - paediatric investigation plan Galcanezumab	Updated
09/10/2026	PIP: EMA/PE/0000238109 - paediatric investigation plan bempedoic acid (ETC-1002)	Updated
09/10/2026	PIP: EMA/PE/0000241641 - paediatric investigation plan Live, attenuated, dengue virus, serotype 1 (DENV1); live, attenuated, chimeric dengue virus, serotype 2 (DENV2); Live, attenuated, dengue virus, serotype 3 (DENV3); Live, attenuated, dengue virus, serotype 4 (DENV4)	Updated
09/10/2026	PIP: EMA/PE/0000242151 - paediatric investigation plan erenumab	Updated
09/10/2026	PIP: EMA/PE/0000243984 - paediatric investigation plan disitamab vedotin	Updated
09/10/2026	PIP: EMA/PE/0000242247 - paediatric investigation plan fitusiran	Updated
09/10/2026	PIP: EMA/PE/0000244179 - paediatric investigation plan Indacaterol (acetate); mometasone (furoate); glycopyrronium bromide	Updated
09/10/2026	Document: Timetable: Extension application - ATMP	Updated
09/10/2026	Document: Timetable: Extension application	Updated
08/10/2026	Scientific guideline: Download website data in JSON data format - Scientific guideline	Updated
08/10/2026	Medicine: Hetronifly serplulimab	Updated
08/10/2026	News: Clinical trial applications advice pilot becomes permanent	New
08/10/2026	Scientific guideline: Demonstration of therapeutic equivalence for nasal products - Scientific guideline	Updated
08/10/2026	Document: Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products	New
08/10/2026	PIP: EMA/PE/0000261512 - paediatric investigation plan Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes	Updated
08/10/2026	Event: Clinical Trials Information System (CTIS): Walk-in clinic October 2026	Updated
08/10/2026	Medicine: Mvasi bevacizumab	Updated
08/10/2026	Document: Agenda - Combination products operational group, MD stream, 8 October 2026	New
08/10/2026	Medicine: Mounjaro tirzepatide	Updated
08/10/2026	Document: Final programming document 2026-28	Updated
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 15-18 September 2025	Updated
08/10/2026	Document: Annex to 15-18 September 2025 CHMP Minutes	New
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2026	Updated
08/10/2026	Document: Annex to 20-23 July 2026 CHMP Minutes	New
08/10/2026	Document: Minutes of the CHMP meeting 20-23 July 2026	New
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2026	Updated
08/10/2026	Document: Annex to 20-23 April 2026 CHMP Minutes	New
08/10/2026	Document: Minutes of the CHMP meeting 20-23 April 2026	New
08/10/2026	Medicine: Tepmetko tepotinib	Updated
08/10/2026	PSUSA: PSUSA/00010947/202602 - periodic safety update report single assessment telmisartan / indapamide	New
08/10/2026	PSUSA: PSUSA/00010280/202602 - periodic safety update report single assessment acetylsalicylic acid / atorvastatin / ramipril	New
08/10/2026	Medicine: Lucentis ranibizumab	Updated
08/10/2026	Medicine: Increlex mecasermin	Updated
08/10/2026	Medicine: Tafamidis Accord tafamidis	Updated
08/10/2026	PSUSA: PSUSA/00001568/202602 - periodic safety update report single assessment granisetron (all formulations except transdermal patch)	New
07/10/2026	PSUSA: PSUSA/00009266/202601 - periodic safety update report single assessment potassium canrenoate	New
07/10/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
07/10/2026	Medicine: Zinmyleo trilaciclib	Updated
07/10/2026	Medicine: Kuvan sapropterin	Updated
07/10/2026	Medicine: Nulibry fosdenopterin	Updated
07/10/2026	Document: Minutes of the HMPC meeting 6-8 July 2026	Updated
07/10/2026	Medicine: Cibinqo abrocitinib	Updated
07/10/2026	Medicine: Imbruvica ibrutinib	Updated
07/10/2026	Medicine: Mysimba naltrexone; bupropion	Updated
07/10/2026	Medicine: Zokinvy lonafarnib	Updated
07/10/2026	Medicine: Ritonavir Viatris (previously Ritonavir Mylan) ritonavir	Updated
07/10/2026	Medicine: Lunsumio mosunetuzumab	Updated
07/10/2026	Medicine: Calquence acalabrutinib	Updated
07/10/2026	Orphan: EU/3/18/2068 - orphan designation for treatment of growth hormone deficiency somapacitan	Updated
07/10/2026	Medicine: Sogroya somapacitan	Updated
07/10/2026	Medicine: Besremi ropeginterferon alfa-2b	Updated
07/10/2026	Medicine: Brukinsa zanubrutinib	Updated
07/10/2026	Medicine: Thiotepa Riemser thiotepa	Updated
07/10/2026	Medicine: Scenesse afamelanotide	Updated
07/10/2026	PSUSA: PSUSA/00001204/202602 - periodic safety update report single assessment eletriptan	New
07/10/2026	PSUSA: PSUSA/00009057/202601 - periodic safety update report single assessment argatroban	New
07/10/2026	Medicine: Cenrifki tolebrutinib	Updated
06/10/2026	Page: PRIME: eligibility requests and outcomes	New
06/10/2026	Page: PRIME: priority medicines	Updated
06/10/2026	Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meetings of 2026	New
06/10/2026	Document: List of medicines currently in PRIME scheme	Updated
06/10/2026	Medicine: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) telmisartan	Updated
06/10/2026	Page: How to submit information on authorised and investigational medicines	Updated
06/10/2026	Page: Reporting requirements for marketing-authorisation holders	Updated
06/10/2026	Medicine: Otulfi ustekinumab	Updated
06/10/2026	Document: PRAC rules of procedure	Updated
06/10/2026	Medicine: Steqeyma ustekinumab	Updated
06/10/2026	Scientific guideline: Good pharmacogenomic practice - Scientific guideline	Updated
06/10/2026	Document: Concept paper on the guideline revision on good pharmacogenomic practice	New
06/10/2026	Event: Management Board meeting: 30 September 2026	Updated
06/10/2026	Document: Agenda - Management Board meeting: 30 September 2026	Updated
06/10/2026	PSUSA: PSUSA/00001584/202602 - periodic safety update report single assessment haemophilus type b conjugate vaccines	New
06/10/2026	PSUSA: PSUSA/00001955/202602 - periodic safety update report single assessment mefloquine	New
06/10/2026	PSUSA: PSUSA/00001248/202602 - periodic safety update report single assessment erdosteine	New
06/10/2026	Event: European Medicines Agency workshop on bacteriophage therapy	Updated
06/10/2026	Medicine: Usymro ustekinumab	Updated
06/10/2026	PSUSA: PSUSA/00001781/202601 - periodic safety update report single assessment ipratropium / salbutamol	New
06/10/2026	PSUSA: PSUSA/00001583/202602 - periodic safety update report single assessment haemophilus type b and meningococcal group C conjugate vaccine	New
06/10/2026	Medicine: Myalepta metreleptin	Updated
06/10/2026	Post-authorisation: Imfinzi - withdrawal of application for variation to marketing authorisation durvalumab	Updated
06/10/2026	PSUSA: PSUSA/00002951/202601 - periodic safety update report single assessment tick-borne encephalitis vaccine (inactivated)	New
06/10/2026	Medicine: Ruxience rituximab	Updated
06/10/2026	Event: Committee for Orphan Medicinal Products (COMP): 6-8 October 2026	Updated
06/10/2026	Document: Agenda of the COMP Meeting 6-8 October 2026	New
06/10/2026	Document: Product Management Service (PMS) - Frequently Asked Questions (FAQs)	Updated
06/10/2026	Event: Ninth European Medicines Agency (EMA) and EFPIA bilateral meeting	Updated
06/10/2026	Medicine: Orladeyo berotralstat	Updated
06/10/2026	Document: Records of data processing activity relating to the management and processing of documents related to absences due to illness or accident and consultations with the occupational health physicians	New
06/10/2026	Event: European platform for regulatory science research meeting: October 2026	Updated
06/10/2026	Page: Developing cancer medicines for children	Updated
06/10/2026	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure	Updated
06/10/2026	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
06/10/2026	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure	Updated
06/10/2026	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
06/10/2026	Document: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical	Updated
06/10/2026	Page: Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union	Updated
06/10/2026	Page: Accelerated assessment	Updated
06/10/2026	Page: Periodic safety update reports (PSURs)	Updated
06/10/2026	Page: Pre-authorisation guidance	Updated
06/10/2026	Page: Type-II variations: questions and answers	Updated
06/10/2026	Page: Extensions of marketing authorisations: questions and answers	Updated
06/10/2026	Page: Type-IA variations: questions and answers	Updated
06/10/2026	Page: Changing the labelling and package leaflet (Article 61(3) notifications)	Updated
06/10/2026	Medicine: Filsuvez birch bark extract	Updated
06/10/2026	Event: Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026	Updated
06/10/2026	Document: Agenda of the CVMP meeting 6-8 October 2026	New
05/10/2026	Medicine: Byooviz ranibizumab	Updated
05/10/2026	Medicine: Ertapenem SUN ertapenem	Updated
05/10/2026	Medicine: Kinzalkomb telmisartan; hydrochlorothiazide	Updated
05/10/2026	Medicine: PritorPlus telmisartan; hydrochlorothiazide	Updated
05/10/2026	Medicine: Aumseqa Aumolertinib	Updated
05/10/2026	Medicine: Aimovig erenumab	Updated
05/10/2026	Document: Minutes of the CHMP meeting 15-18 September 2025	New
05/10/2026	Medicine: Hexacima diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Updated
05/10/2026	PSUSA: PSUSA/00011084/202603 - periodic safety update report single assessment dienogest / ethinylestradiol	New
05/10/2026	Medicine: Hexyon diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Updated
05/10/2026	Medicine: Opdualag relatlimab; nivolumab	Updated
05/10/2026	PSUSA: PSUSA/00000110/202601 - periodic safety update report single assessment alprostadil	New
05/10/2026	Document: Minutes of the CAT meeting 12-14 August 2026	New
05/10/2026	Document: Minutes of the CAT meeting 15-17 July 2026	New
05/10/2026	Document: User manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)	Updated
05/10/2026	Event: Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection	Updated
05/10/2026	Event: First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting	Updated
02/10/2026	PSUSA: PSUSA/00002550/202601 - periodic safety update report single assessment propafenone	New
02/10/2026	Medicine: Orgovyx relugolix	Updated
02/10/2026	Medicine: Ziextenzo pegfilgrastim	Updated
02/10/2026	Event: Regulatory sandboxes: Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop	Updated
02/10/2026	Medicine: Arsenic trioxide Accord arsenic trioxide	Updated
02/10/2026	PIP: EMA/PE/0000302950 - paediatric investigation plan humanised IgG4 bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor A, long form	New
02/10/2026	PIP: EMA/PE/0000291645 - paediatric investigation plan mRNA encoding Human cytomegalovirus UL128; mRNA encoding Human cytomegalovirus UL130; mRNA encoding Human cytomegalovirus UL131A; mRNA encoding Human cytomegalovirus glycoprotein H; mRNA encoding Human cytomegalovirus glycoprotein B; mRNA encoding Human cytomegalovirus glycoprotein L	Updated
02/10/2026	Medicine: Rasilez aliskiren	Updated
02/10/2026	Medicine: Ordspono odronextamab	Updated
02/10/2026	Medicine: Sialanar glycopyrronium bromide	Updated
02/10/2026	Medicine: Andembry garadacimab	Updated
02/10/2026	Medicine: Sprycel dasatinib (anhydrous)	Updated
02/10/2026	Page: Procedural timetables	Updated
02/10/2026	Event: Committee for Herbal Medicinal Products (HMPC): 6-8 July 2026	Updated
02/10/2026	Document: List of centrally authorised products with safety-related changes to the product information	Updated
02/10/2026	News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October	New
02/10/2026	Medicine: Itvisma onasemnogene abeparvovec	Updated
02/10/2026	Medicine: Bysumlog insulin lispro	Updated
02/10/2026	EU-M4all: Ivermectin/Albendazole - opinion on medicine for use outside EU ivermectin; albendazole	Updated
02/10/2026	Event: Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)	Updated
02/10/2026	Medicine: Riltrava Aerosphere formoterol fumarate dihydrate; glycopyrronium; budesonide	Updated
02/10/2026	Medicine: Leqvio inclisiran	Updated
02/10/2026	Medicine: Ebvallo tabelecleucel	Updated
02/10/2026	Page: External whistleblowing policy	Updated
02/10/2026	Medicine: Byetta exenatide	Updated
02/10/2026	Document: Policy 0072: Policy on the handling of information from external persons on breaches related to the authorisation, supervision and maintenance of human and veterinary medicinal products or other EMA activities	Updated
02/10/2026	Medicine: Bydureon exenatide	Updated
02/10/2026	Medicine: Adzynma rADAMTS13	Updated
01/10/2026	Medicine: Constella linaclotide	Updated
01/10/2026	Medicine: Sibnayal potassium citrate; potassium hydrogen carbonate	Updated
01/10/2026	Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party	Updated
01/10/2026	Document: Meeting summary - Medicine shortages SPOC working party meeting 15 July 2026	New
01/10/2026	Medicine: Degevma denosumab	Updated
01/10/2026	News: Advice on ‘end-of-year’ submission dates for type I variations in 2026	New
01/10/2026	News: EMA Management Board: highlights of September 2026 meeting	New
01/10/2026	Document: Proceedings for the nomination and appointment of the next EMA Executive Director	New
01/10/2026	Medicine: Epruvy (previously Ranibizumab Midas) ranibizumab	Updated
01/10/2026	Page: International Coalition of Medicines Regulatory Authorities (ICMRA)	Updated
01/10/2026	News: Global regulators call for advancing alternatives to animal testing across the medicine lifecycle	New
01/10/2026	Page: EudraVigilance: electronic reporting	Updated
01/10/2026	News: Executive Director speech at EMA women’s health multi-stakeholder workshop	New
01/10/2026	Medicine: Pomalidomide Teva pomalidomide	Updated

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