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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 (201)

Date Content Status
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-derived 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: Fymskina ustekinumab
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
Event: Seventeenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
 New
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