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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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Date Content Status
22/05/2026
Document: Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
 Updated
22/05/2026
Document: Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
 Updated
22/05/2026
Medicine: Adempas riociguat
Updated
22/05/2026
News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
 New
22/05/2026
Medicine: Uplizna inebilizumab
Updated
22/05/2026
Post-authorisation: Respivac aMPV (previously Respivac TRT) - opinion on variation to marketing authorisation turkey rhinotracheitis virus, strain 1062, live
New
22/05/2026
Page: Scientific and technical recommendations: Veterinary Medicines Regulation
 Updated
22/05/2026
Medicine: Nobivac NXT HCP felid herpesvirus 1, strain G2620A, live; feline calicivirus, strain F9, live; feline panleucopenia virus, strain MW-1, live
New
22/05/2026
Medicine: Nobivac NXT HC feline calicivirosis and feline viral rhinotracheitis vaccine (live)
New
22/05/2026
Medicine: Nobivac NXT HCPCh feline calicivirosis, feline rhinotracheitis, feline panleucopenia and feline chlamydiosis (live) vaccine
New
22/05/2026
Document: Questions to EMA on midazolam
 New
22/05/2026
Document: EC letter to EMA - Request pursuant to Article 141(1)(f) of Regulation (EU) 2019/6
 New
22/05/2026
Document: Guidance under Article 141(1)(f) of Regulation (EU) 2019/6 on veterinary medicinal products with regards five substances not included in Commission Implementing Regulation (EU) 2025/901
 New
22/05/2026
Document: Questions for CVMP in relation to EMA’s recommendations under Article 107(6) and Article 114(3)
 New
22/05/2026
Document: Guidance under Article 141(1)(f) of Regulation (EU) 2019/6 on veterinary medicinal products in relation to Articles 107(6) and 114(3)
 New
22/05/2026
Document: EC request to EMA for guidance on scientific issues in relation to Articles 107(6) and 114(3) of Regulation (EU) 2019/6
 New
22/05/2026
Medicine: Piasky crovalimab
Updated
22/05/2026
Medicine: Yttriga yttrium [90Y] chloride
Updated
22/05/2026
Medicine: Yuvanci macitentan; tadalafil
Updated
22/05/2026
Medicine: Mekinist trametinib
Updated
22/05/2026
Medicine: Sephience sepiapterin
Updated
22/05/2026
Post-authorisation: BTVPUR - opinion on variation to marketing authorisation inactivated vaccine against bluetongue virus serotypes 1 and 8
New
22/05/2026
Medicine: Jubereq denosumab
Updated
22/05/2026
Medicine: Osvyrti denosumab
Updated
22/05/2026
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
 New
22/05/2026
Post-authorisation: Braftovi - opinion on variation to marketing authorisation encorafenib
New
22/05/2026
Post-authorisation: Tepkinly - opinion on variation to marketing authorisation epcoritamab
New
22/05/2026
Post-authorisation: Iclusig - opinion on variation to marketing authorisation ponatinib
New
22/05/2026
Medicine: Colchicine Agepha Pharma colchicine
New
22/05/2026
Orphan: EU/3/22/2727 - orphan designation for diagnosis of neuroendocrine neoplasms Copper (64Cu) oxodotreotide
Updated
22/05/2026
Orphan: EU/3/21/2420 - orphan designation for treatment of PIK3CA related overgrowth spectrum alpelisib
Updated
22/05/2026
Orphan: EU/3/14/1390 - orphan designation for treatment of hereditary haemorrhagic telangiectasia bevacizumab
Updated
22/05/2026
News: New medicine for two types of pulmonary fibrosis
 New
22/05/2026
News: First oral GLP-1 treatment for weight management
 New
22/05/2026
News: First medicine to treat rare uncontrolled growth of body tissues
 New
22/05/2026
Medicine: Deqtynet copper (64Cu) oxodotreotide
New
22/05/2026
Medicine: Ablymico liraglutide
New
22/05/2026
Medicine: Vijoice alpelisib
New
22/05/2026
Medicine: Etcamah camizestrant
New
22/05/2026
Medicine: Vislyfa ranibizumab
New
22/05/2026
Medicine: Orblid bevacizumab
New
22/05/2026
Medicine: Liraglutide STADA liraglutide
New
22/05/2026
Medicine: Veblocema infliximab
New
22/05/2026
Post-authorisation: Erbitux - opinion on variation to marketing authorisation cetuximab
New
22/05/2026
Post-authorisation: Palynziq - opinion on variation to marketing authorisation pegvaliase
New
22/05/2026
Post-authorisation: Wegovy - opinion on variation to marketing authorisation semaglutide
New
22/05/2026
Post-authorisation: Erbitux - opinion on variation to marketing authorisation cetuximab
New
22/05/2026
Post-authorisation: Keytruda - opinion on variation to marketing authorisation pembrolizumab
New
22/05/2026
Post-authorisation: Maviret - opinion on variation to marketing authorisation glecaprevir; pibrentasvir
New
22/05/2026
Post-authorisation: Padcev - opinion on variation to marketing authorisation enfortumab vedotin
New
22/05/2026
Post-authorisation: Fasenra - opinion on variation to marketing authorisation benralizumab
New
22/05/2026
Post-authorisation: Enhertu - opinion on variation to marketing authorisation trastuzumab deruxtecan
New
22/05/2026
Post-authorisation: Hetronifly - opinion on variation to marketing authorisation serplulimab
New
22/05/2026
Post-authorisation: Trodelvy - opinion on variation to marketing authorisation sacituzumab govitecan
New
22/05/2026
Post-authorisation: Sogroya - opinion on variation to marketing authorisation somapacitan
New
22/05/2026
Post-authorisation: Keytruda - opinion on variation to marketing authorisation pembrolizumab
New
22/05/2026
Document: Overview of (invented) names reviewed in April 2026 by the Name Review Group (NRG) adopted at the CHMP meeting of 21 May 2026
 New
22/05/2026
Page: Hantavirus
 New
22/05/2026
PSUSA: PSUSA/00003006/202503 - periodic safety update report single assessment tranexamic acid
Updated
21/05/2026
Medicine: Nuwiq simoctocog alfa
Updated
21/05/2026
Medicine: Zoledronic acid Teva zoledronic acid
Updated
21/05/2026
Medicine: Bavencio avelumab
Updated
21/05/2026
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 April 2026
 New
21/05/2026
Medicine: Exjade deferasirox
Updated
21/05/2026
Medicine: Ceprotin human protein C
Updated
21/05/2026
Document: List of eligible industry stakeholder organisations
 Updated
21/05/2026
Medicine: Kisqali ribociclib
Updated
21/05/2026
News: EMA closed on Whit Monday, 25 May
 New
21/05/2026
Page: Website outages and upgrades
 Updated
21/05/2026
Medicine: Pyrukynd mitapivat
Updated
21/05/2026
Document: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
 Updated
21/05/2026
Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - November 2026
 New
21/05/2026
Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - October 2026
 New
20/05/2026
Medicine: Ruconest conestat alfa
Updated
20/05/2026
Medicine: Feraccru ferric maltol
Updated
20/05/2026
Medicine: Ryeqo relugolix; estradiol; norethisterone acetate
Updated
20/05/2026
Medicine: Xofluza baloxavir marboxil
Updated
20/05/2026
Page: Data Analysis and Real World Interrogation Network (DARWIN EU)
 Updated
20/05/2026
Medicine: Mimpara cinacalcet
Updated
20/05/2026
Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
 New
20/05/2026
Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
 New
20/05/2026
Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
 New
20/05/2026
Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
 New
20/05/2026
Medicine: Iloperidone Vanda Pharmaceuticals iloperidone
Updated
20/05/2026
Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 4-6 May 2026
 New
20/05/2026
Medicine: Dazparda insulin aspart
Updated
20/05/2026
Event: Webinar on new approach methodologies (NAMs) in ecotoxicology: In silico approaches for fish acute toxicity
 New
20/05/2026
News: EU tracks progress towards 2030 clinical trial targets
New
20/05/2026
Page: Clinical trials in human medicines
 Updated
20/05/2026
Medicine: Cerdelga eliglustat
Updated
19/05/2026
Medicine: Arava leflunomide
Updated
19/05/2026
Medicine: Synflorix pneumococcal polysaccharide conjugate vaccine (adsorbed)
Updated
19/05/2026
Medicine: Tecartus brexucabtagene autoleucel
Updated
19/05/2026
Page: Product-specific bioequivalence guidance
 Updated
19/05/2026
Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 March 2026 - 23 April 2026)
 New
19/05/2026
Medicine: Cimzia certolizumab pegol
Updated
19/05/2026
Medicine: Yescarta axicabtagene ciloleucel
Updated
19/05/2026
Medicine: Tuyory tocilizumab
Updated
19/05/2026
Medicine: Tafinlar dabrafenib
Updated
19/05/2026
Document: Agenda of the CVMP meeting 19-21 May 2026
 New
19/05/2026
Document: Presentation - CTIS Bitesize Talk: End of transition period and notifications including serious breaches
 Updated
19/05/2026
Medicine: Spexotras trametinib
Updated
19/05/2026
Medicine: Voranigo vorasidenib
Updated
19/05/2026
Medicine: Procysbi mercaptamine
Updated
19/05/2026
Medicine: Arexvy recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
Updated
19/05/2026
Medicine: Zoledronic acid medac zoledronic acid
Updated
19/05/2026
Document: Application form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency
 Updated
19/05/2026
Medicine: Ibrance palbociclib
Updated
19/05/2026
Page: Executive Steering Group on Shortages of Medical Devices
 Updated
18/05/2026
Orphan: EU/3/16/1716 - orphan designation for treatment of Duchenne muscular dystrophy adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
Updated
18/05/2026
Orphan: EU/3/25/3114 - orphan designation for treatment of alpha-1 antitrypsin deficiency RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt
Updated
18/05/2026
Page: Ebola
 Updated
18/05/2026
Medicine: Ixchiq Chikungunya vaccine (live)
Updated
18/05/2026
Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 February 2026 - 26 March 2026)
 New
18/05/2026
Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (30 January 2026 - 26 February 2026)
 New
18/05/2026
Medicine: Paxlovid nirmatrelvir; ritonavir
Updated
18/05/2026
Document: Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
 Updated
18/05/2026
Document: Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes
 Updated
18/05/2026
Medicine: Besponsa inotuzumab ozogamicin
Updated
18/05/2026
Medicine: Zercepac trastuzumab
Updated
18/05/2026
Medicine: Imfinzi durvalumab
Updated
18/05/2026
Document: Highlights from the third expert panels and notified bodies workshop
 New
18/05/2026
Medicine: Usrenty ustekinumab
Updated
18/05/2026
Event: EMA risk management information day
 New
18/05/2026
Document: Highlights from the second expert panels and notified bodies workshop
 New
18/05/2026
Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2026
 Updated
18/05/2026
Document: Annex to agenda of the CHMP meeting 18-21 May 2026
 New
18/05/2026
Document: Agenda of the CHMP meeting 18-21 May 2026
 New
18/05/2026
Medicine: Sapropterin Dipharma sapropterin
Updated
18/05/2026
Orphan: EU/3/25/3159 - orphan designation for treatment of idiopathic pulmonary fibrosis orvepitant maleate
Updated
18/05/2026
Orphan: EU/3/20/2376 - orphan designation for treatment of congenital hyperinsulinism 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide
Updated
18/05/2026
Orphan: EU/3/22/2731 - orphan designation for treatment of small cell lung cancer serplulimab
Updated
18/05/2026
Orphan: EU/3/04/230 - orphan designation for treatment of cystic fibrosis Dexamethasone sodium phosphate encapsulated in human erythrocytes
Updated
18/05/2026
Orphan: EU/3/13/1158 - orphan designation for treatment of ataxia telangiectasia Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes
Updated
18/05/2026
Orphan: EU/3/18/2004 - orphan designation for treatment of diffuse large B-cell lymphoma tazemetostat
Updated
18/05/2026
Orphan: EU/3/18/2006 - orphan designation for treatment of malignant mesothelioma tazemetostat
Updated
18/05/2026
Orphan: EU/3/24/2989 - orphan designation for treatment of systemic sclerosis avenciguat
Updated
18/05/2026
Orphan: EU/3/12/1010 - orphan designation for treatment of Becker muscular dystrophy ataluren
Updated
18/05/2026
Orphan: EU/3/20/2333 - orphan designation for treatment of peripheral T-cell lymphoma tipifarnib
Updated
18/05/2026
Orphan: EU/3/15/1561 - orphan designation for treatment of aniridia ataluren
Updated
18/05/2026
Orphan: EU/3/05/269 - orphan designation for treatment of acute myeloid leukaemia tipifarnib
Updated
18/05/2026
Orphan: EU/3/24/2966 - orphan designation for treatment of gastric cancer bemarituzumab
Updated
18/05/2026
Orphan: EU/3/13/1108 - orphan designation for treatment of systemic sclerosis 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid
Updated
18/05/2026
Orphan: EU/3/17/1854 - orphan designation for treatment of thromboangiitis obliterans (Buerger's disease) autologous adipose tissue-derived mesenchymal stem cells
Updated
18/05/2026
Orphan: EU/3/10/842 - orphan designation for treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy nimorazole
Updated
18/05/2026
Orphan: EU/3/10/823 - orphan designation for treatment of familial chylomicronaemia Lomitapide
Updated
18/05/2026
Orphan: EU/3/11/937 - orphan designation for treatment of Leigh syndrome alpha-tocotrienol quinone
Updated
18/05/2026
Medicine: Imvanex smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Updated
18/05/2026
Orphan: EU/3/22/2654 - orphan designation for treatment of fibrodysplasia ossificans progressiva (S)-1-(4-(1-(3,4,5-trimethoxyphenyl)-1H-imidazol-4-ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2-carboxamide
Updated
13/05/2026
Referral: Levamisole-containing medicinal products - referral levamisole
Updated
13/05/2026
Medicine: Lucentis ranibizumab
Updated
13/05/2026
DHPC: Tecovirimat SIGA - direct healthcare professional communication (DHPC) tecovirimat monohydrate
Updated
13/05/2026
DHPC: Ontozry - direct healthcare professional communication (DHPC) cenobamate
New
13/05/2026
Medicine: Iclusig ponatinib
Updated
13/05/2026
Medicine: Aspaveli pegcetacoplan
Updated
13/05/2026
Medicine: EndolucinBeta lutetium (177Lu) chloride
Updated
13/05/2026
Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)
 Updated
13/05/2026
Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables
 Updated
13/05/2026
Document: Timetable: Initial (Full) marketing authorisation application - ATMP
 Updated
13/05/2026
Document: Timetable: Informed consent and multiple application
 Updated
13/05/2026
Document: Timetable: Extension application
 Updated
13/05/2026
Document: Timetable: Accelerated assessment request for initial marketing authorisations - ATMP
 Updated
13/05/2026
Document: Timetable accelerated assessment request for initial marketing authorisation applications
 Updated
13/05/2026
Orphan: EU/3/17/1971 - orphan designation for treatment of RARS2 syndrome vatiquinone
Updated
13/05/2026
Orphan: EU/3/21/2536 - orphan designation for treatment of Alpers-Huttenlocher syndrome vatiquinone
Updated
13/05/2026
Orphan: EU/3/22/2573 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes vatiquinone
Updated
13/05/2026
Orphan: EU/3/20/2383 - orphan designation for treatment of respiratory distress syndrome perflubron
Updated
13/05/2026
Orphan: EU/3/18/2114 - orphan designation for treatment in solid organ transplantation C1 esterase inhibitor (human)
Updated
13/05/2026
Orphan: EU/3/13/1184 - orphan designation for treatment of sickle cell disease
 Updated
13/05/2026
Document: Timetable: Extension application - ATMP
 Updated
13/05/2026
Medicine: Hetronifly serplulimab
Updated
13/05/2026
Document: HMPC meetings in 2025 and 2026
 Updated
13/05/2026
Document: HMPC: overview of assessment work - priority list
 Updated
13/05/2026
Medicine: Rivastigmine Hexal rivastigmine
Updated
12/05/2026
Herbal: Fragariae folium - herbal medicinal product Wild Strawberry Leaf
Updated
12/05/2026
Medicine: Sotyktu deucravacitinib
Updated
12/05/2026
Page: Development and manufacture of synthetic peptides - Scientific guideline
 Updated
12/05/2026
Page: Parallel scientific advice and special development aspects or product types
 Updated
12/05/2026
Medicine: Ezmekly mirdametinib
Updated
12/05/2026
Page: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices
 Updated
12/05/2026
Medicine: Xbonzy denosumab
Updated
12/05/2026
Medicine: Evrenzo roxadustat
Updated
12/05/2026
Medicine: Olazax Disperzi olanzapine
Updated
12/05/2026
Medicine: Zoledronic acid Actavis zoledronic acid
Updated
12/05/2026
News: EMA actively monitoring cruise ship Hantavirus outbreak
 New
12/05/2026
Medicine: Zoledronic Acid Hospira zoledronic acid
Updated
12/05/2026
News: EMA business hours over Ascension Day holidays, 14 and 15 May
 New
12/05/2026
Document: Article 57 product data
 Updated
12/05/2026
Event: Workshop on Vulnerability Assessment
 Updated
12/05/2026
Medicine: Emepax maropitant
Updated
12/05/2026
Medicine: Xolremdi mavorixafor
Updated
12/05/2026
PSUSA: PSUSA/00002540/202509 - periodic safety update report single assessment progesterone
New
12/05/2026
Medicine: AviGate S. Infantis Salmonella Infantis vaccine (live)
Updated
12/05/2026
Medicine: VeroBlue-3 bluetongue virus vaccine (inactivated)
Updated
12/05/2026
News: EMA welcomes political agreement on Critical Medicines Act
 New
12/05/2026
Document: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical
 Updated
11/05/2026
Medicine: Lenalidomide Mylan lenalidomide
Updated
11/05/2026
Medicine: Olazax olanzapine
Updated
11/05/2026
Medicine: Tobi Podhaler tobramycin
Updated
11/05/2026
Medicine: Camcevi leuprorelin
Updated
11/05/2026
Medicine: Imuldosa ustekinumab
Updated
11/05/2026
PSUSA: PSUSA/00002702/202509 - periodic safety update report single assessment silver sulfadiazine
New
11/05/2026
PSUSA: PSUSA/00002904/202509 - periodic safety update report single assessment terizidone
New
11/05/2026
PSUSA: PSUSA/00010582/202509 - periodic safety update report single assessment allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)
New
11/05/2026
Medicine: Omlyclo omalizumab
Updated
11/05/2026
Medicine: Exdensur depemokimab
Updated
11/05/2026
Medicine: Qalsody tofersen
Updated
11/05/2026
Medicine: Amglidia glibenclamide
Updated
11/05/2026
Medicine: Giotrif afatinib
Updated
11/05/2026
Medicine: Orencia abatacept
Updated
11/05/2026
Medicine: Denbrayce denosumab
Updated
11/05/2026
Document: Agenda of the CAT meeting 11-13 May 2026
 New
11/05/2026
Document: Applications for new human medicines under evaluation: May 2026
 New
11/05/2026
Herbal: Hamamelidis cortex - herbal medicinal product Hamamelis Bark
Updated
11/05/2026
Herbal: Hamamelidis folium - herbal medicinal product Hamamelis Leaf
Updated
11/05/2026
Herbal: Hamamelidis folium et cortex aut ramunculus destillatum - herbal medicinal product Hamamelis Distillate
Updated
11/05/2026
Document: Antimicrobial Sales and Use (ASU) Platform: Release notes
 Updated
11/05/2026
Document: Olazax : EPAR - Procedural steps taken and scientific information after authorisation (archive)
 Updated
11/05/2026
Document: Agenda - EnprEMA & ACT EU workshop on paediatric clinical trials
 Updated
11/05/2026
Medicine: Ojemda tovorafenib
Updated
11/05/2026
Orphan: EU/3/21/2477 - orphan designation for treatment of otoferlin gene-mediated hearing loss Adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene, adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene
Updated
11/05/2026
Orphan: EU/3/23/2779 - orphan designation for treatment of neurofibromatosis type 1 2-((2-fluoro-4-iodophenyl)amino)-N-(2-hydroxyethoxy)-1-methyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide
Updated
11/05/2026
Orphan: EU/3/21/2510 - orphan designation for treatment of hypoparathyroidism encaleret
Updated
11/05/2026
Orphan: EU/3/22/2641 - orphan designation for treatment of myelodysplastic syndromes eltanexor
Updated
11/05/2026
Orphan: EU/3/14/1317 - orphan designation for treatment of diffuse large B-cell lymphoma (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide
Updated
11/05/2026
Orphan: EU/3/14/1354 - orphan designation for treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma selinexor
Updated
11/05/2026
Orphan: EU/3/22/2705 - orphan designation for treatment of myelofibrosis selinexor
Updated
11/05/2026
Orphan: EU/3/21/2509 - orphan designation for treatment of glioma selinexor
Updated
11/05/2026
Orphan: EU/3/14/1313 - orphan designation for treatment of acute myeloid leukaemia (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide
Updated
11/05/2026
Orphan: EU/3/25/3071 - orphan designation for treatment of primary sclerosing cholangitis beta-lapachone
Updated
11/05/2026
Orphan: EU/3/21/2470 - orphan designation for treatment of amyotrophic lateral sclerosis pridopidine hydrochloride
Updated
11/05/2026
Orphan: EU/3/05/288 - orphan designation for treatment of Huntington’s disease 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride)
Updated
11/05/2026
Event: Breakthrough medical devices: information session
 Updated
11/05/2026
Document: Agenda of the COMP Meeting 11-12 May 2026
 New
08/05/2026
Document: PDCO minutes of the 24-27 March 2026 meeting
 New
08/05/2026
Page: PRIME: priority medicines
 Updated
08/05/2026
PSUSA: PSUSA/00001232/202507 - periodic safety update report single assessment epinephrine (except for nasal use)
New
08/05/2026
PSUSA: PSUSA/00000626/202508 - periodic safety update report single assessment choline salicylate, cetalkonium chloride
New
08/05/2026
Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 April 2026
 New
08/05/2026
Document: List of medicines currently in PRIME scheme
 Updated
08/05/2026
Medicine: Olanzapine Glenmark Europe olanzapine
Updated
08/05/2026
Medicine: Olanzapine Glenmark olanzapine
Updated
08/05/2026
Medicine: Elebrato Ellipta fluticasone furoate; umeclidinium; vilanterol
Updated
08/05/2026
Medicine: Trelegy Ellipta fluticasone furoate; umeclidinium; vilanterol
Updated
08/05/2026
Medicine: Opdivo nivolumab
Updated
08/05/2026
EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda - opinion on medicine for use outside EU dengue tetravalent vaccine (live, attenuated)
Updated
08/05/2026
Medicine: Remsima infliximab
Updated
08/05/2026
PSUSA: PSUSA/00002434/202508 - periodic safety update report single assessment piretanide / ramipril, piretanide
New
08/05/2026
Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Updated
08/05/2026
PSUSA: PSUSA/00000448/202508 - periodic safety update report single assessment buclizine / codeine / paracetamol, caffeine / codeine / paracetamol
New
08/05/2026
Medicine: Genvoya elvitegravir; cobicistat; emtricitabine; tenofovir alafenamide
Updated
08/05/2026
Medicine: Ixiaro Japanese encephalitis vaccine (inactivated, adsorbed)
Updated
08/05/2026
Medicine: Gardasil 9 human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Updated
08/05/2026
Medicine: Loargys pegzilarginase
Updated
08/05/2026
Medicine: Teriflunomide Viatris (previously Teriflunomide Mylan) teriflunomide
Updated
08/05/2026
Medicine: Esbriet pirfenidone
Updated
08/05/2026
Medicine: Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) tenofovir disoproxil
Updated
08/05/2026
Medicine: Bimzelx bimekizumab
Updated
08/05/2026
Medicine: Teduglutide Viatris teduglutide
Updated
08/05/2026
Medicine: Bylvay odevixibat
Updated
08/05/2026
Medicine: Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Updated
08/05/2026
Medicine: Latuda lurasidone
Updated
08/05/2026
Medicine: Talmanco (previously Tadalafil Generics) tadalafil
Updated
08/05/2026
Medicine: Rivaroxaban Viatris (previously Rivaroxaban Mylan) rivaroxaban
Updated
08/05/2026
Medicine: Ritonavir Viatris (previously Ritonavir Mylan) ritonavir
Updated
08/05/2026
Medicine: Itovebi inavolisib
Updated
08/05/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026
 New
08/05/2026
Medicine: Pregabalin Viatris (previously Pregabalin Mylan) pregabalin
Updated
08/05/2026
Event: Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
 New
08/05/2026
Medicine: Pomalidomide Viatris pomalidomide
Updated
08/05/2026
Medicine: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris emtricitabine; rilpivirine; tenofovir alafenamide
Updated
08/05/2026
Medicine: Mayzent siponimod
Updated
08/05/2026
PIP: EMEA-001976-PIP02-18 - paediatric investigation plan 3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594)
Updated
08/05/2026
PIP: EMEA-001017-PIP01-10-M01 - paediatric investigation plan chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Updated
08/05/2026
PIP: EMEA-002183-PIP03-23 - paediatric investigation plan imlifidase
Updated
08/05/2026
PIP: EMEA-001013-PIP01-10-M01 - paediatric investigation plan chemically modified extract of trees pollen from birch and alder
Updated
08/05/2026
PIP: EMEA-001011-PIP01-10-M01 - paediatric investigation plan chemically modified house dust mites allergen extract of Dermatophagoides pteronyssinus and Dermatophagoides farina
Updated
08/05/2026
PIP: EMEA-001374-PIP01-12 - paediatric investigation plan exon 53 specific phosphorothioate oligonucleotide
Updated
08/05/2026
PIP: EMEA-001369-PIP01-12 - paediatric investigation plan exon 45 specific phosphorothioate oligonucleotide
Updated
08/05/2026
Medicine: Nintedanib Viatris nintedanib
Updated
08/05/2026
PIP: EMEA-002051-PIP02-16 - paediatric investigation plan allopregnanolone
Updated
08/05/2026
Medicine: Kanjinti trastuzumab
Updated
08/05/2026
Medicine: Teizeild teplizumab
Updated
08/05/2026
Page: Revamp of marketing authorisation assessment templates
 New
08/05/2026
Medicine: Dupixent dupilumab
Updated
08/05/2026
PSUSA: PSUSA/00002357/202508 - periodic safety update report single assessment pethidine
New
07/05/2026
Medicine: Mysildecard sildenafil
Updated
07/05/2026
Medicine: Febuxostat Viatris (previously Febuxostat Mylan) febuxostat
Updated
07/05/2026
Medicine: Entecavir Viatris (previously Entecavir Mylan) entecavir
Updated
07/05/2026
Medicine: Eltrombopag Viatris eltrombopag
Updated
07/05/2026
Medicine: Duloxetine Viatris (previously Duloxetine Mylan) duloxetine
Updated
07/05/2026
Medicine: Darunavir Viatris (previously Darunavir Mylan) darunavir
Updated
07/05/2026
Medicine: Ibandronic Acid Sandoz ibandronic acid
Updated
07/05/2026
Medicine: Dapagliflozin Viatris dapagliflozin
Updated
07/05/2026
Medicine: Cinacalcet Viatris (previously Cinacalcet Mylan) cinacalcet
Updated
07/05/2026
Medicine: Rapilysin reteplase
Updated
07/05/2026
Medicine: Afiveg aflibercept
Updated
07/05/2026
Medicine: Ambrisentan Viatris (previously Ambrisentan Mylan) ambrisentan
Updated
07/05/2026
Medicine: Loqtorzi toripalimab
Updated
07/05/2026
Medicine: Humira adalimumab
Updated
07/05/2026
Medicine: Atazanavir Viatris (previously Atazanavir Mylan) atazanavir
Updated
07/05/2026
Medicine: Ilumetri tildrakizumab
Updated
07/05/2026
Medicine: Comtan entacapone
Updated
07/05/2026
Medicine: Arixtra fondaparinux sodium
Updated
07/05/2026
News: EU recommendations for 2026/2027 seasonal flu vaccine composition
 Updated
07/05/2026
Medicine: Fintepla fenfluramine
Updated
07/05/2026
Medicine: Uzpruvo ustekinumab
Updated
07/05/2026
Medicine: Dimethyl fumarate Mylan dimethyl fumarate
Updated
07/05/2026
Medicine: Beovu brolucizumab
Updated
07/05/2026
Medicine: Truvelog Mix 30 insulin aspart
Updated
07/05/2026
PIP: EMEA-003192-PIP03-23 - paediatric investigation plan ensitrelvir
New
07/05/2026
PIP: EMA/PE/0000230710 - paediatric investigation plan rocatinlimab
Updated
07/05/2026
Medicine: CellCept mycophenolate mofetil
Updated
07/05/2026
Medicine: Olumiant baricitinib
Updated
07/05/2026
Medicine: Kerendia finerenone
Updated
07/05/2026
Medicine: Dovprela (previously Pretomanid FGK) pretomanid
Updated
07/05/2026
Medicine: Oncaspar pegaspargase
Updated
07/05/2026
Document: List of industry subject matter experts and list of planned calls for industry subject matter experts
 Updated
07/05/2026
Document: Record of data processing activity for Modelling and Simulation Pilot - Use of clinical study data for scientific advice
 New
07/05/2026
Document: European Medicines Agency's data protection notice for Modelling and Simulation Pilot - Use of clinical study data for scientific advice
 New
07/05/2026
Event: Clinical Trials Information System (CTIS): Information day
 New
07/05/2026
Medicine: Usgena ustekinumab
Updated
06/05/2026
Document: Minutes of PRAC meeting on 9-12 March 2026
 New
06/05/2026
Shortage: NexoBrid concentrate of proteolytic enzymes enriched in bromelain
New
06/05/2026
Medicine: Tolucombi telmisartan; hydrochlorothiazide
Updated
06/05/2026
PIP: EMA/PE/0000181993 - paediatric investigation plan mosunetuzumab
Updated
06/05/2026
PIP: EMA/PE/0000290054 - paediatric investigation plan human polyclonal immunoglobulin G against thymocyte
New
06/05/2026
PIP: EMA/PE/0000236886 - paediatric investigation plan baricitinib
New
06/05/2026
Medicine: Integrilin eptifibatide
Updated
06/05/2026
PIP: EMEA-002414-PIP01-18 - paediatric investigation plan Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871)
Updated
06/05/2026
PIP: EMEA-002299-PIP01-17 - paediatric investigation plan Enfortumab vedotin
Updated
06/05/2026
Medicine: Imcivree setmelanotide
Updated
06/05/2026
Medicine: Korjuny catumaxomab
Updated
06/05/2026
Medicine: Truqap capivasertib
Updated
06/05/2026
Medicine: Ifirmasta (previously Irbesartan Krka) irbesartan
Updated
06/05/2026
Medicine: Irbesartan Teva irbesartan
Updated
06/05/2026
Medicine: Ogsiveo nirogacestat
Updated
05/05/2026
Medicine: Rhapsido remibrutinib
Updated
05/05/2026
Document: Agenda of the PRAC meeting 4-7 May 2026
 Updated
05/05/2026
Document: European Medicines Agency’s data protection notice for the management of traineeships at EMA
 New
05/05/2026
Document: Minutes of the CAT meeting 18-20 March 2026
 New
05/05/2026
Document: Minutes of the COMP meeting 17-18 March 2026
 New
05/05/2026
Page: Quality of medicines: questions and answers - Part 2
 Updated
05/05/2026
Document: Questions and answers on implementation of Ph.Eur. Medicinal Product Monographs (MPM)
 Updated
05/05/2026
Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)
Updated
05/05/2026
Medicine: Onerji levodopa; carbidopa
Updated
05/05/2026
Medicine: Palsonify paltusotine
Updated
05/05/2026
Medicine: Ilaris canakinumab
Updated
05/05/2026
Document: QRD veterinary combined label-leaflet template v.9.1
 Updated
05/05/2026
Medicine: Mvabea Ebola vaccine (MVA-BN-Filo [recombinant])
Updated
05/05/2026
Medicine: Zabdeno ebola vaccine (Ad26.ZEBOV-GP [recombinant])
Updated
05/05/2026
Medicine: Qutenza capsaicin
Updated
05/05/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
04/05/2026
Document: Template - Request for compliance check on an agreed paediatric investigation plan (PIP)
 Updated
04/05/2026
Document: FAQs: Supervise a Clinical Trial : Inspection records - CTIS Training Programme - Module 16
 Updated
04/05/2026
Event: European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry
 Updated
04/05/2026
Document: Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 March 2026
 New
04/05/2026
Document: Minutes of the Management Board meeting: 12 March 2026
 New
04/05/2026
Document: Minutes - Executive Steering Group on Shortages of Medical Devices (MDSSG) (23 March 2026)
 New
04/05/2026
Shortage: Quetiapine
 Updated
04/05/2026
Event: Pharmacovigilance Risk Assessment Committee (PRAC): 4 - 7 May 2026
 Updated
04/05/2026
Document: Agenda of the COMP Meeting 14-16 April 2026
 Updated
04/05/2026
Event: Product Management Service (PMS) information day 2026
 Updated
04/05/2026
Medicine: Leqembi lecanemab
Updated
04/05/2026
Medicine: Rapamune sirolimus
Updated
04/05/2026
Medicine: Yeytuo lenacapavir
Updated
04/05/2026
Page: PRAC recommendations on safety signals
 Updated
04/05/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
04/05/2026
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 April 2026 PRAC
 New
04/05/2026
Document: PRAC recommendations on signals adopted at the 7-10 April 2026 PRAC meeting
 New