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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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Results (177)

Date Content Status
11/09/2026
Medicine: Aybintio bevacizumab
Updated
11/09/2026
Medicine: Saphnelo anifrolumab
Updated
11/09/2026
Medicine: Vyloy zolbetuximab
Updated
11/09/2026
Medicine: Repaglinide Accord repaglinide
Updated
11/09/2026
Medicine: Bilprevda denosumab
Updated
11/09/2026
Medicine: Emgality galcanezumab
Updated
11/09/2026
Medicine: Lynkuet elinzanetant
Updated
11/09/2026
Medicine: Cirbloc porcine circovirus vaccine (inactivated)
New
11/09/2026
Medicine: AviGate S. Typhimurium Salmonella enterica, subsp. enterica, serovar Typhimurium, strain Nal2/Rif9/Rtt, Live
New
11/09/2026
News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026
 New
11/09/2026
Post-authorisation: Firocoxib CP-Pharma - opinion on variation to marketing authorisation firocoxib
New
11/09/2026
Post-authorisation: Vectra 3D - opinion on variation to marketing authorisation dinotefuran, permethrin, and pyriproxyfen
New
11/09/2026
Post-authorisation: Vectormune HVT-AIV - opinion on variation to marketing authorisation Avian influenza vaccine
New
11/09/2026
Post-authorisation: Felpreva - opinion on variation to marketing authorisation emodepside; praziquantel; tigolaner
New
11/09/2026
Page: ICH M12 on drug interaction studies - Scientific guideline
 Updated
11/09/2026
Document: Draft guideline on the investigation of interactions in the gastrointestinal tract
 New
10/09/2026
Event: HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations
 Updated
10/09/2026
Referral: Veterinary medicinal products containing amoxicillin - referral amoxicillin
Updated
10/09/2026
Medicine: Xeljanz tofacitinib
Updated
10/09/2026
Medicine: Uzpruvo ustekinumab
Updated
10/09/2026
Medicine: Zoledronic acid Mylan zoledronic acid
Updated
10/09/2026
Medicine: Tagrisso osimertinib
Updated
10/09/2026
Medicine: Moventig naloxegol
Updated
10/09/2026
Event: First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting
 New
10/09/2026
Event: Fifth European Medicines Agency (EMA) - Vaccines Europe bilateral meeting
 New
10/09/2026
Event: Product Management Service (PMS) public API beta release - Technical overview and live demo
 Updated
10/09/2026
Page: Clinical investigation of medicinal products for treatment of migraine - Scientific guideline
 Updated
10/09/2026
Document: Draft guideline on clinical investigation of medicinal products for the treatment of migraine and cluster headache - Revision 2
 New
09/09/2026
PSUSA: PSUSA/00000405/202601 - periodic safety update report single assessment bezafibrate
New
09/09/2026
Medicine: Amvuttra vutrisiran
Updated
09/09/2026
Page: Expert panel support for orphan medical devices
 Updated
09/09/2026
Document: Orphan medical devices regular process: 2027 timetable
 New
09/09/2026
Page: Scientific advice for high-risk medical devices
 Updated
09/09/2026
Medicine: Perjeta pertuzumab
Updated
09/09/2026
Document: Advice to medical device manufacturers - 2027 Timetable
 New
09/09/2026
Medicine: Zilbrysq zilucoplan
Updated
09/09/2026
Medicine: Zercepac trastuzumab
Updated
09/09/2026
Medicine: Colchicine Agepha Pharma colchicine
Updated
09/09/2026
Event: EMA Biotech Hub and Technology Transfer Offices (TTOs) engagement workshop
New
09/09/2026
Document: Agenda of the PRAC meeting 31 August - 3 September 2026
 Updated
09/09/2026
Document: Electronic submission of Article 57(2) data: questions and answers
 Updated
09/09/2026
Document: Chapter 3.II: XEVPRM detailed user guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
 Updated
09/09/2026
Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting details
 Updated
09/09/2026
Event: 2026 annual open meeting of the European Network of Paediatric Research at EMA (EnprEMA)
 New
09/09/2026
Document: Applications for new human medicines under evaluation: September 2026
 New
09/09/2026
Shortage: Eskazole / Zentel albendazole
New
09/09/2026
Shortage: Natpar parathyroid hormone
Updated
09/09/2026
Medicine: Qezzaqar catequentinib
Updated
09/09/2026
Page: Good pharmacovigilance practices (GVP)
 Updated
09/09/2026
Document: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections
 New
09/09/2026
Document: Guideline on good pharmacovigilance practices: Module III - Pharmacovigilance inspections (Rev. 2) with tracked changes
 New
09/09/2026
Document: Guideline on good pharmacovigilance practices: Module III - Pharmacovigilance inspections (Rev. 2)
 New
09/09/2026
Document: Agenda of the CAT meeting 9-11 September 2026
 New
08/09/2026
Medicine: Benlysta belimumab
Updated
08/09/2026
Medicine: Rinvoq upadacitinib
Updated
08/09/2026
Medicine: Sivextro tedizolid phosphate
Updated
08/09/2026
Medicine: Suliqua insulin glargine; lixisenatide
Updated
08/09/2026
Medicine: Lucentis ranibizumab
Updated
08/09/2026
Medicine: Bexsero meningococcal group B Vaccine (rDNA, component, adsorbed)
Updated
08/09/2026
Medicine: Vislyfa ranibizumab
Updated
08/09/2026
Medicine: Lupkynis voclosporin
Updated
08/09/2026
Medicine: Kavigale sipavibart
Updated
08/09/2026
Medicine: Rezolsta darunavir; cobicistat
Updated
08/09/2026
PSUSA: PSUSA/00003159/202512 - periodic safety update report single assessment antithrombin III
New
08/09/2026
Document: Agenda of the CVMP meeting 8-10 September 2026
 New
08/09/2026
PSUSA: PSUSA/00010710/202601 - periodic safety update report single assessment alitretinoin (oral use)
New
08/09/2026
Medicine: Olumiant baricitinib
Updated
08/09/2026
Document: Member states contact points for translations review
 Updated
08/09/2026
Medicine: Gardasil 9 human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Updated
07/09/2026
Event: EMA/FVE information session for veterinary students: the importance of pharmacovigilance
 New
07/09/2026
Medicine: Xolremdi mavorixafor
Updated
07/09/2026
Document: Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
 Updated
07/09/2026
Medicine: Fymskina ustekinumab
Updated
07/09/2026
Document: Agenda - PDCO agenda of the 8-11 September 2026 meeting
 New
07/09/2026
Medicine: Arava leflunomide
Updated
07/09/2026
Medicine: Nordimet methotrexate
Updated
07/09/2026
Medicine: Jylamvo methotrexate
Updated
07/09/2026
Document: Agenda of the COMP Meeting 8-10 September 2026
 New
07/09/2026
PSUSA: PSUSA/00000560/202601 - periodic safety update report single assessment carboprost
New
07/09/2026
Event: EMA Methodology Working Party interested parties meeting 2026
 New
07/09/2026
PSUSA: PSUSA/00000164/202601 - periodic safety update report single assessment aminophylline
New
07/09/2026
Page: QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures
 Updated
07/09/2026
Document: Guidance on the revised pre-submission interactions model
 Updated
04/09/2026
Document: Targeted signal management (TSM) for Phenobarbital in cats and dogs
 New
04/09/2026
Page: Signal management (veterinary medicines)
 Updated
04/09/2026
PSUSA: PSUSA/00010465/202512 - periodic safety update report single assessment allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet)
New
04/09/2026
PSUSA: PSUSA/00000269/202601 - periodic safety update report single assessment atropine / diphenoxylate
New
04/09/2026
Shortage: Visudyne verteporfin
Updated
04/09/2026
PSUSA: PSUSA/00001345/202512 - periodic safety update report single assessment exemestane
New
04/09/2026
PSUSA: PSUSA/00000495/202601 - periodic safety update report single assessment calcitriol
New
04/09/2026
PSUSA: PSUSA/00002695/202601 - periodic safety update report single assessment sertindole
New
04/09/2026
Medicine: Symtuza darunavir; cobicistat; emtricitabine; tenofovir alafenamide
Updated
04/09/2026
EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda - opinion on medicine for use outside EU dengue tetravalent vaccine (live, attenuated)
Updated
04/09/2026
Medicine: Qdenga dengue tetravalent vaccine (live, attenuated)
Updated
04/09/2026
PSUSA: PSUSA/00000378/202601 - periodic safety update report single assessment benzydamine / cetylpyridine
New
04/09/2026
PSUSA: PSUSA/00010510/202601 - periodic safety update report single assessment beta-alanine
New
04/09/2026
Medicine: Riximyo rituximab
Updated
04/09/2026
Page: Pharmacogenomics
 New
04/09/2026
Medicine: Rixathon rituximab
Updated
04/09/2026
Page: Union Product Database: release notes
 Updated
04/09/2026
Medicine: Miglustat Dipharma miglustat
Updated
04/09/2026
Document: Guidance for applicants on how to submit ePI in centralised procedures
 New
04/09/2026
Page: Electronic product information (ePI)
 Updated
04/09/2026
Referral: Parenteral iron-containing medicinal products - referral ferric carboxymaltose; ferric derisomaltose; ferric gluconate; ferric hydroxide polymaltose complex; iron dextran; iron sucrose
New
04/09/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
 New
04/09/2026
News: Executive Director's speech at Duke-NUS Medical School in Singapore
 New
04/09/2026
Page: COVID-19 medicines
 Updated
04/09/2026
PIP: EMA/PE/0000338563 - paediatric investigation plan omaveloxolone
New
04/09/2026
Page: Scientific advice and protocol assistance
 Updated
04/09/2026
Page: Framework for interaction with pharmaceutical industry stakeholders
 Updated
04/09/2026
Page: Pharmaceutical industry: Getting involved in EMA activities
 New
04/09/2026
Medicine: Repatha evolocumab
Updated
04/09/2026
News: New EU supply chain to end Visudyne shortage
 New
04/09/2026
Page: Women's health
 Updated
04/09/2026
Page: Scientific and technical recommendations: Veterinary Medicines Regulation
 Updated
03/09/2026
Medicine: Onureg azacitidine
Updated
03/09/2026
Document: Sponsor guidance: New safety module on the annual safety report
 Updated
03/09/2026
Page: Support to SMEs
 Updated
03/09/2026
PSUSA: PSUSA/00000414/202601 - periodic safety update report single assessment biotin
New
03/09/2026
PSUSA: PSUSA/00010209/202601 - periodic safety update report single assessment cilostazol
New
03/09/2026
Herbal: Fragariae folium - herbal medicinal product Wild Strawberry Leaf
Updated
03/09/2026
Medicine: Pomalidomide Krka pomalidomide
Updated
03/09/2026
Medicine: Velsipity etrasimod
Updated
03/09/2026
Medicine: Emtricitabine/Tenofovir disoproxil Mylan emtricitabine; tenofovir disoproxil
Updated
03/09/2026
Medicine: Ambrisentan Viatris (previously Ambrisentan Mylan) ambrisentan
Updated
03/09/2026
Page: Podcast: Inside EMA
 Updated
03/09/2026
Medicine: Keytruda pembrolizumab
Updated
03/09/2026
Event: Quarterly System Demo - Q3 2026
 Updated
03/09/2026
Document: Minutes of PRAC meeting on 8-11 June 2026
 New
03/09/2026
Document: EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal
 Updated
02/09/2026
Medicine: Bexatil Bexagliflozin
Updated
02/09/2026
Page: Plasma master file certificates
 Updated
02/09/2026
Medicine: Emtricitabine/Tenofovir disoproxil Zentiva emtricitabine; tenofovir disoproxil
Updated
02/09/2026
Medicine: Rebif interferon beta-1a
Updated
02/09/2026
Medicine: Prasugrel Viatris (previously Prasugrel Mylan) prasugrel
Updated
02/09/2026
Medicine: Ngenla somatrogon
Updated
02/09/2026
Medicine: Ogsiveo nirogacestat
Updated
02/09/2026
Medicine: Ezmekly mirdametinib
Updated
02/09/2026
Medicine: Cinacalcet Accordpharma cinacalcet
Updated
02/09/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
 Updated
02/09/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
 Updated
02/09/2026
Page: Pre-authorisation guidance
 Updated
02/09/2026
Page: Pre-submission interactions model pilot
 New
02/09/2026
Document: Pilot phase for the revised pre-submission interactions: Annex to request for rapporteurship
 New
02/09/2026
Document: Pre-submission interactions form for marketing authorisation application
 New
02/09/2026
Document: EU submission, timelines and review talk (EUSTART)
 New
02/09/2026
Medicine: Yaxwer denosumab
Updated
02/09/2026
Medicine: Imvanex smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Updated
02/09/2026
Medicine: Lokelma sodium zirconium cyclosilicate
Updated
02/09/2026
Medicine: Cibinqo abrocitinib
Updated
02/09/2026
Page: Assessment templates and guidance (veterinary medicines)
 Updated
02/09/2026
Shortage: Saxenda liraglutide
Updated
02/09/2026
Document: Template - CVMP member comments on rapporteur’s reports
 Updated
02/09/2026
Document: Information required for early identification of a need for pre-authorisation GMP inspections
 Updated
02/09/2026
Shortage: Brevibloc esmolol
New
01/09/2026
Page: Portfolio and technology meetings
 Updated
01/09/2026
Medicine: Kymriah tisagenlecleucel
Updated
01/09/2026
Event: Managing product data quality in PMS: processes, known issues, current status and best practices
 Updated
01/09/2026
Medicine: Myqorzo aficamten
Updated
01/09/2026
Medicine: Omvoh mirikizumab
Updated
01/09/2026
Medicine: Seffalair Spiromax salmeterol; fluticasone propionate
Updated
01/09/2026
Page: Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing
 Updated
01/09/2026
News: Voluntary data submission pilot to advance innovative alternatives to animal testing
 New
01/09/2026
Page: New approach methodologies to replace and reduce animal testing: Voluntary data submission pilot
 New
01/09/2026
Document: Voluntary data submission (VDS) pilot information document
 New
01/09/2026
Document: Voluntary data submission (VDS) pilot application form
 New
01/09/2026
Medicine: Aujemflu Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture)
Updated
01/09/2026
Medicine: Zadenvi denosumab
Updated
01/09/2026
Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) in IRIS - Frequently asked questions
 Updated
01/09/2026
Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants
 Updated
01/09/2026
Event: 20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP)
 Updated
01/09/2026
Page: Task Forces
 Updated
01/09/2026
Document: Organisation chart: Task Forces
 Updated
01/09/2026
Page: Veterinary Medicines
 Updated
01/09/2026
Document: Organisation chart: Veterinary Medicines
 Updated
01/09/2026
Document: Highlight report from the 16th industry stakeholder platform on research and development support
 New
01/09/2026
Page: Expert panel support for breakthrough medical devices: pilot programme
 Updated