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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 (293)

Date Content Status
20/08/2026
Medicine: Lacosamide UCB lacosamide
Updated
20/08/2026
Medicine: Junod denosumab
Updated
20/08/2026
Medicine: Xolremdi mavorixafor
Updated
20/08/2026
Medicine: Vimpat lacosamide
Updated
20/08/2026
Medicine: Epidyolex cannabidiol
Updated
20/08/2026
Medicine: MabThera rituximab
Updated
20/08/2026
Medicine: Instanyl fentanyl
Updated
20/08/2026
Medicine: Epivir lamivudine
Updated
20/08/2026
Medicine: Ocrevus ocrelizumab
Updated
20/08/2026
Document: Timetable: Post-authorisation measure (PAM) assessed by PRAC
 Updated
20/08/2026
Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP
 Updated
20/08/2026
Medicine: Rivastigmine 1 A Pharma rivastigmine
Updated
20/08/2026
Medicine: Rivastigmine Hexal rivastigmine
Updated
20/08/2026
Medicine: Rivastigmine Sandoz rivastigmine
Updated
20/08/2026
Document: Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
 Updated
20/08/2026
Document: Timetable: Companion diagnostic follow-up consultation
 Updated
20/08/2026
Document: Timetable: Companion diagnostic follow-up consultation - ATMP
 Updated
20/08/2026
Document: Timetable: Companion diagnostic initial consultation
 Updated
20/08/2026
Document: Timetable: Companion diagnostic initial consultation - ATMP
 Updated
20/08/2026
Document: Timetable: Type II variation and worksharing application monthly assessment
 Updated
20/08/2026
Medicine: Arexvy Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)
Updated
20/08/2026
Medicine: Kesimpta ofatumumab
Updated
20/08/2026
Medicine: Zolgensma onasemnogene abeparvovec
Updated
20/08/2026
Medicine: Ryeqo relugolix; estradiol; norethisterone acetate
Updated
20/08/2026
DHPC: Jentadueto - direct healthcare professional communication (DHPC) linagliptin; metformin hydrochloride
New
20/08/2026
Medicine: Samsca tolvaptan
Updated
19/08/2026
Document: International Pharmaceutical Abstracts (IPA) journals
 Updated
19/08/2026
Document: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Description of the Journal/Reference databases used
 Updated
19/08/2026
Medicine: Tyenne tocilizumab
Updated
19/08/2026
Medicine: Rubraca rucaparib
Updated
19/08/2026
Medicine: Kisqali ribociclib
Updated
19/08/2026
Medicine: Vanflyta quizartinib
Updated
19/08/2026
Medicine: Skyclarys omaveloxolone
Updated
19/08/2026
Medicine: Andembry garadacimab
Updated
19/08/2026
Medicine: Tavneos avacopan
Updated
19/08/2026
Medicine: Nivestim filgrastim
Updated
19/08/2026
Medicine: Nucala mepolizumab
Updated
19/08/2026
Medicine: Opdivo nivolumab
Updated
19/08/2026
Event: EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU
 Updated
19/08/2026
Document: Product Management Service (PMS) public API - Frequently asked questions (FAQs)
 Updated
19/08/2026
Medicine: Kaftrio ivacaftor; tezacaftor; elexacaftor
Updated
19/08/2026
Medicine: Alyftrek deutivacaftor / tezacaftor / vanzacaftor
Updated
19/08/2026
Medicine: Jinarc tolvaptan
Updated
19/08/2026
Medicine: Ryzneuta efbemalenograstim alfa
Updated
19/08/2026
EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda - opinion on medicine for use outside EU dengue tetravalent vaccine (live, attenuated)
Updated
19/08/2026
Medicine: Febuxostat Viatris (previously Febuxostat Mylan) febuxostat
Updated
19/08/2026
Medicine: Qdenga dengue tetravalent vaccine (live, attenuated)
Updated
19/08/2026
Page: Pre-authorisation guidance
 Updated
19/08/2026
Medicine: Inrebic fedratinib
Updated
19/08/2026
Medicine: Xeljanz tofacitinib
Updated
19/08/2026
Document: Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
 Updated
19/08/2026
Document: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
 Updated
19/08/2026
Document: EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
 Updated
19/08/2026
Document: Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes
 Updated
19/08/2026
Document: Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
 Updated
19/08/2026
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)
 Updated
19/08/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
 Updated
19/08/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
 Updated
19/08/2026
Page: Marketing authorisation (veterinary medicines)
 Updated
19/08/2026
Document: Veterinary medicines marketing authorisation application pre-submission interaction request form
 Updated
19/08/2026
Medicine: Prolia denosumab
Updated
18/08/2026
Page: Accessibility
 Updated
18/08/2026
Medicine: Herwenda trastuzumab
Updated
18/08/2026
Medicine: Tagrisso osimertinib
Updated
18/08/2026
Medicine: Arixtra fondaparinux sodium
Updated
18/08/2026
Medicine: Alimta pemetrexed
Updated
18/08/2026
Medicine: Parsabiv etelcalcetide
Updated
18/08/2026
Document: Medicinal products for human use: monthly figures - July 2026
 New
18/08/2026
Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission
 Updated
18/08/2026
Event: Webinar on new approach methodologies (NAMs) in ecotoxicology: QSARs to predict aquatic toxicity
 New
18/08/2026
Document: Timetable: Post-authorisation measure (PAM) assessed by CHMP
 Updated
18/08/2026
Document: Timetable: Post-authorisation measure (PAM) assessed by CAT
 Updated
18/08/2026
Medicine: Mounjaro tirzepatide
Updated
18/08/2026
Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMP
 Updated
18/08/2026
Medicine: Stelara ustekinumab
Updated
18/08/2026
Medicine: Brilique ticagrelor
Updated
18/08/2026
Medicine: Tuznue trastuzumab
Updated
18/08/2026
Medicine: Amgevita adalimumab
Updated
18/08/2026
Medicine: Yaxwer denosumab
Updated
18/08/2026
PSUSA: PSUSA/00000548/202510 - periodic safety update report single assessment carbidopa / levodopa
New
18/08/2026
Medicine: Dupixent dupilumab
Updated
18/08/2026
Medicine: Conexxence denosumab
Updated
18/08/2026
Post-authorisation: Dupixent - withdrawal of application for variation to marketing authorisation dupilumab
Updated
18/08/2026
Medicine: Temodal temozolomide
Updated
18/08/2026
Medicine: Akeega niraparib; abiraterone acetate
Updated
18/08/2026
Medicine: MenQuadfi meningococcal group A, C, W-135 and Y conjugate vaccine
Updated
18/08/2026
Medicine: Vislyfa ranibizumab
Updated
18/08/2026
Page: International Coalition of Medicines Regulatory Authorities (ICMRA)
 Updated
17/08/2026
Medicine: Rinvoq upadacitinib
Updated
17/08/2026
Event: Shortage prevention plan (SPP) workshop
 Updated
17/08/2026
Document: Draft data standards framework
 New
17/08/2026
Medicine: Pheburane sodium phenylbutyrate
Updated
17/08/2026
Document: Minutes of the Management Board meeting: 10-11 June 2026
 New
17/08/2026
Document: Shortage prevention plan (SPP) workshop report
 New
14/08/2026
Medicine: Fulphila pegfilgrastim
Updated
14/08/2026
Medicine: Lutathera lutetium (177Lu) oxodotreotide
Updated
14/08/2026
Page: Scientific publications
 Updated
14/08/2026
Page: Artificial intelligence
 Updated
14/08/2026
Medicine: Vafseo vadadustat
Updated
14/08/2026
Document: European Medicines Agency’s data protection notice on 360 assessment
 New
14/08/2026
Document: Presentation - AI and digital technologies transforming cardiovascular device in novation (S. Zenker)
 New
14/08/2026
Document: Presentation - Artificial intelligence for drug development in cardiovascular medicine (C. Mittman)
 New
14/08/2026
Document: Presentation - AI in cardiovascular care (F. Asselbergs)
 New
14/08/2026
Document: Presentation - Fostering innovation in cardiovascular diseases with digitalisationand AI (K. Azer)
 New
14/08/2026
Medicine: Tuzulby methylphenidate hydrochloride
Updated
14/08/2026
Document: Presentation - Experience gained and lessons learned from recent and ongoing initiatives (A. Segec)
 New
14/08/2026
Document: Presentation - Emerging and innovative devices - state of play and key questions (J. Russo)
 New
14/08/2026
Document: Presentation - Emerging and innovative therapies - state of play and key questions (O. Vedin)
 New
14/08/2026
Document: Presentation - Challenges and opportunities in medicines development (A. Baczynska)
 New
14/08/2026
PIP: EMA/PE/0000232482 - paediatric investigation plan tegoprubart
New
13/08/2026
Event: Digitalisation and artificial Intelligence in pharmaceutical manufacturing: Quality Innovation Group (QIG) - Follow-up roundtable meeting
 Updated
13/08/2026
Medicine: KemSu sufentanil; ketamine
Updated
13/08/2026
Document: Presentation - Challenges and opportunities in medicines and medical devices development (S. Dias)
 New
13/08/2026
Document: Presentation - Adiposity: The gateway to cardiometabolic diseases (L. Fábryová)
 New
13/08/2026
Document: Presentation - Cardiometabolic diseases: Tackling the unmet need in CV risk reduction (F. Giorgino)
 New
13/08/2026
Document: Presentation - Cardiometabolic diseases: tackling the unmet need in cardiovascular risk reduction (J. Nabais)
 New
13/08/2026
Document: Presentation - Global collaboration in cardiovascular medicine development (M. Inoue)
 New
13/08/2026
Document: Presentation - Clinical imperatives for implementing regulatory science for medical devices (A. Fraser)
 New
13/08/2026
Document: Presentation - Recent (regulatory) developments in medicines for cardiovascular indications (A. Irs)
 New
13/08/2026
Document: Presentation - Clinical research: opportunties and challenges (T. Lüscher)
 New
13/08/2026
Document: Presentation - The safe hearts plan (Y. Azzopardi)
New
13/08/2026
Document: Presentation - Lived experience in unmet need (M. Holler)
 New
13/08/2026
Medicine: Pyrukynd mitapivat
Updated
13/08/2026
Medicine: Ezmekly mirdametinib
Updated
13/08/2026
Medicine: Exdensur depemokimab
Updated
13/08/2026
Medicine: Osenvelt denosumab
Updated
13/08/2026
PSUSA: PSUSA/00002420/202510 - periodic safety update report single assessment pipamperone
New
13/08/2026
Page: Reliance for post-authorisation changes pilots
 Updated
13/08/2026
Document: Meeting report: Regulators-only workshop on reliance for post-approval changes (PACs) 18–19 May 2026
 New
13/08/2026
Document: Reliance for postauthorisation changes (PACs): Mid-pilot review
 New
13/08/2026
Event: Industry webinar on new electronic application form (eAF) version
 Updated
13/08/2026
Medicine: Voxzogo vosoritide
Updated
13/08/2026
Referral: Tavneos - referral avacopan
Updated
13/08/2026
PSUSA: PSUSA/00000820/202511 - periodic safety update report single assessment acetylsalicylic acid / clopidogrel, clopidogrel
New
13/08/2026
Medicine: RoActemra tocilizumab
Updated
13/08/2026
PSUSA: PSUSA/00002896/202509 - periodic safety update report single assessment terbinafine
New
13/08/2026
Medicine: Lupkynis voclosporin
Updated
13/08/2026
Page: Reliance for post-authorisation changes: guidance for the pharmaceutical industry
 New
12/08/2026
Medicine: Lynparza olaparib
Updated
12/08/2026
Page: What we publish on medicines and when
 Updated
12/08/2026
Page: Vaccines: concerns, questions and false claims
 Updated
12/08/2026
Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations
 New
12/08/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
12/08/2026
Page: Performance enhancers - Scientific guideline
 Updated
12/08/2026
Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)
 Updated
12/08/2026
Event: 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan
 Updated
12/08/2026
Page: Opinions and letters of support on the qualification of novel methodologies for medicine development
 Updated
12/08/2026
Document: Annex 4 - Big MS Data (BMSD) feasibility study
 New
12/08/2026
Document: Annex 1 - Qualification opinion briefing book for the Big MS Data network registries on Post Authorization Safety Studies
 New
12/08/2026
Document: Annex 2 - Observational long-term safety surveillance registry studies in the Big MS Data (BMSD) network
 New
12/08/2026
Document: Draft qualification opinion for the Big Multiple Sclerosis Data (BMSD) network
 New
12/08/2026
Document: Annex 5 - Initial Qualification Procedure - List of Issues - Big MS Data Network (BMSD) and incorporated multiple sclerosis (MS)
 New
12/08/2026
Document: Process for the electronic submission of medicinal product information - Chapter 3
 Updated
12/08/2026
Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - tracked changes
 Updated
12/08/2026
Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
 Updated
11/08/2026
Page: Fees for veterinary medicines
 Updated
11/08/2026
Medicine: Zebinix eslicarbazepine acetate
Updated
11/08/2026
Medicine: Tecfidera dimethyl fumarate
Updated
11/08/2026
Page: Fees for human medicines
 Updated
11/08/2026
Medicine: Usgena ustekinumab
Updated
11/08/2026
Medicine: Kanjinti trastuzumab
Updated
11/08/2026
Event: Clinical Trials Information System (CTIS): Walk-in clinic October 2026
 New
11/08/2026
Document: HMPC: overview of assessment work - priority list
 Updated
11/08/2026
Medicine: Yesintek ustekinumab
Updated
10/08/2026
Page: Vaccine Monitoring Platform
 Updated
10/08/2026
Medicine: Boey trenibotulinumtoxinE
Updated
10/08/2026
PIP: EMA/PE/0000273488 - paediatric investigation plan rocatinlimab
Updated
10/08/2026
Post-authorisation: Jivi - opinion on variation to marketing authorisation damoctocog alfa pegol
New
10/08/2026
PIP: EMEA-002886-PIP03-24 - paediatric investigation plan rocatinlimab
Updated
10/08/2026
Document: Vaccine Monitoring Platform (VMP) research agenda - Update 2026
 Updated
10/08/2026
Document: Vaccine Monitoring Platform (VMP) research agenda
 Updated
10/08/2026
Medicine: Oncept IL-2 feline interleukin-2 recombinant canarypox virus (vCP1338 virus)
Updated
10/08/2026
Medicine: Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted)
Updated
10/08/2026
DHPC: Litfulo - direct healthcare professional communication (DHPC) ritlecitinib tosilate
New
10/08/2026
Document: Name Review Group (NRG) plenary meeting dates: 2026-2027
 Updated
10/08/2026
Document: Article 57 product data
 Updated
10/08/2026
Document: European Medicines Agency’s data protection notice for committees, Working Parties (WPs), Scientific Advisory Groups (SAGs) and Ad-Hoc Expert Groups (AHEGs)
 Updated
10/08/2026
Document: Minutes of the COMP meeting 16-18 June 2026
 New
10/08/2026
Page: PRIME: priority medicines
 Updated
10/08/2026
Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 July 2026
 New
10/08/2026
Document: List of medicines currently in PRIME scheme
 Updated
07/08/2026
Page: Medicine shortages and availability issues: guidance for companies
 Updated
07/08/2026
Medicine: Lacosamide Adroiq lacosamide
Updated
07/08/2026
Medicine: Epysqli eculizumab
Updated
07/08/2026
Medicine: Imvanex smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)
Updated
07/08/2026
PSUSA: PSUSA/00010462/202510 - periodic safety update report single assessment bisoprolol / perindopril
New
07/08/2026
PSUSA: PSUSA/00000419/202509 - periodic safety update report single assessment bisoprolol
New
07/08/2026
Medicine: Scemblix asciminib
Updated
07/08/2026
Document: Presentation - Why are NAMs important? (S. Ponzano)
 New
07/08/2026
Document: Applications for new human medicines under evaluation: August 2026
 New
07/08/2026
Medicine: Tecvayli teclistamab
Updated
07/08/2026
Medicine: Spedra avanafil
Updated
07/08/2026
Medicine: Hexacima diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Updated
07/08/2026
Medicine: Hexyon diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Updated
07/08/2026
Page: CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device
 Updated
07/08/2026
Event: Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) new safety module
 Updated
07/08/2026
Document: Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation
 New
06/08/2026
Medicine: Vumerity diroximel fumarate
Updated
06/08/2026
Medicine: Hyftor sirolimus
Updated
06/08/2026
Medicine: Tenkasi (previously Orbactiv) oritavancin
Updated
06/08/2026
Medicine: Docetaxel Kabi docetaxel
Updated
06/08/2026
Medicine: Synjardy empagliflozin; metformin
Updated
06/08/2026
Medicine: Zynlonta loncastuximab tesirine
Updated
06/08/2026
Medicine: Thiotepa Riemser thiotepa
Updated
06/08/2026
Medicine: Neuraceq florbetaben (18F)
Updated
06/08/2026
Medicine: Cholib fenofibrate; simvastatin
Updated
06/08/2026
Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)
Updated
06/08/2026
Medicine: Breyanzi lisocabtagene maraleucel
Updated
06/08/2026
Medicine: Idacio adalimumab
Updated
06/08/2026
Medicine: Firazyr icatibant
Updated
06/08/2026
Medicine: Tepkinly epcoritamab
Updated
06/08/2026
Medicine: Cibinqo abrocitinib
Updated
06/08/2026
Medicine: Ozawade pitolisant
Updated
06/08/2026
Page: Expert panel support for breakthrough medical devices: pilot programme
 Updated
06/08/2026
Medicine: Deqtynet copper (64Cu) oxodotreotide
Updated
06/08/2026
Event: Quarterly System Demo - Q3 2026
 Updated
06/08/2026
Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine
Updated
06/08/2026
Document: Minutes - Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2026
 New
06/08/2026
Page: Fees payable to the European Medicines Agency: Guidance for all applicants
 Updated
06/08/2026
Medicine: Wakix pitolisant
Updated
06/08/2026
DHPC: Desogestrel / etonogestrel - direct healthcare professional communication (DHPC) desogestrel; etonogestrel
New
05/08/2026
PSUSA: PSUSA/00000736/202509 - periodic safety update report single assessment choriogonadotropin alfa, chorionic gonadotrophin
New
05/08/2026
PSUSA: PSUSA/00000669/202512 - periodic safety update report single assessment chlorhexidine gluconate / isopropyl alcohol (covers other synonymous terms such as 2-propanol)
New
05/08/2026
Medicine: Degarelix Accord degarelix
Updated
05/08/2026
Medicine: Ninlaro ixazomib
Updated
05/08/2026
Medicine: Nexpovio selinexor
Updated
05/08/2026
Medicine: Kyprolis carfilzomib
Updated
05/08/2026
Medicine: Rolufta Ellipta (previously Rolufta) umeclidinium
Updated
05/08/2026
Medicine: Humira adalimumab
Updated
05/08/2026
Medicine: Leqembi lecanemab
Updated
05/08/2026
Medicine: Arikayce liposomal amikacin
Updated
05/08/2026
Medicine: Signifor pasireotide
Updated
05/08/2026
Medicine: Iqirvo elafibranor
Updated
05/08/2026
Medicine: Caprelsa vandetanib
Updated
05/08/2026
Medicine: Vantobra (previously Tobramycin PARI) tobramycin
Updated
04/08/2026
Medicine: Loqtorzi toripalimab
Updated
04/08/2026
Medicine: Silapo epoetin zeta
Updated
04/08/2026
Medicine: Elmiron pentosan polysulfate sodium
Updated
04/08/2026
Medicine: Obodence denosumab
Updated
04/08/2026
Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)
Updated
04/08/2026
Orphan: EU/3/19/2183 - orphan designation for treatment of WHIM syndrome mavorixafor
Updated
04/08/2026
Medicine: Dzuveo sufentanil
Updated
04/08/2026
Medicine: Vyxeos liposomal (previously Vyxeos) daunorubicin; cytarabine
Updated
04/08/2026
Orphan: EU/3/26/3201 - orphan designation for treatment of mesothelioma Measles virus Schwarz strain (live, attenuated)
Updated
04/08/2026
Orphan: EU/3/24/3012 - orphan designation for treatment of hepatitis delta virus infection tobevibart
Updated
04/08/2026
Orphan: EU/3/24/3010 - orphan designation for treatment of hepatitis delta virus infection elebsiran
Updated
04/08/2026
Orphan: EU/3/21/2475 - orphan designation for treatment of achondroplasia Infigratinib
Updated
04/08/2026
Medicine: Qinlock ripretinib
Updated
04/08/2026
Orphan: EU/3/15/1450 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine tumours Gallium (68Ga)-edotreotide
Updated
04/08/2026
Orphan: EU/3/07/523 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine tumours Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide (lutetium (177Lu) oxodotreotide)
Updated
04/08/2026
Orphan: EU/3/25/3118 - orphan designation for treatment of primary hyperoxaluria mRNA encoding Cas12HF endonuclease, Single guide RNA against the human HAO1 gene
Updated
04/08/2026
Orphan: EU/3/25/3032 - orphan designation for treatment of Olmsted syndrome (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl)pyrrolidin-1-yl)(5-hydroxy-6-methylpyridin-2-yl)methanone
Updated
04/08/2026
Orphan: EU/3/20/2286 - orphan designation for treatment of soft tissue sarcoma autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4
Updated
04/08/2026
Medicine: SomaKit TOC edotreotide
Updated
04/08/2026
Page: United for health at WorldPride 2026
 New
04/08/2026
Medicine: Orserdu elacestrant
Updated
04/08/2026
Medicine: Vitrakvi larotrectinib
Updated
04/08/2026
Medicine: Spinraza nusinersen
Updated
04/08/2026
PSUSA: PSUSA/00003186/202511 - periodic safety update report single assessment a-tocopheril, a-tocopherol, vitamin E
New
04/08/2026
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 Updated
04/08/2026
Document: Retinal stimulation systems - Notified Body 0344 - 12/06/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
 New
04/08/2026
Medicine: Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) irbesartan; hydrochlorothiazide
Updated
04/08/2026
Medicine: Leflunomide medac leflunomide
Updated
04/08/2026
Medicine: Twinrix Adult hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Updated
04/08/2026
Medicine: Orblid bevacizumab
Updated
04/08/2026
Orphan: EU/3/14/1262 - orphan designation for prevention of bronchopulmonary dysplasia recombinant human surfactant protein D
Updated
04/08/2026
Page: Enpr-EMA priority activities
 Updated
04/08/2026
Document: Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 June 2026
 New
04/08/2026
Page: Plasma master file certificates
 Updated
04/08/2026
Orphan: EU/3/16/1694 - orphan designation for treatment of soft tissue sarcoma autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1
Updated
04/08/2026
Document: Silapo : EPAR - All Authorised presentations
 Updated
03/08/2026
Medicine: Vabysmo faricimab
Updated
03/08/2026
Medicine: Clopidogrel Zentiva (previously Clopidogrel Winthrop) clopidogrel
Updated
03/08/2026
Medicine: Takhzyro lanadelumab
Updated
03/08/2026
Medicine: Lytenava bevacizumab
Updated
03/08/2026
Medicine: Opzelura ruxolitinib
Updated
03/08/2026
Medicine: Palsonify paltusotine
Updated
03/08/2026
Medicine: Ambirix hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Updated
03/08/2026
Medicine: Twinrix Paediatric hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Updated
03/08/2026
Referral: Veterinary medicinal products containing albendazole as a single active substance presented as oral suspension in sheep - referral albendazole
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03/08/2026
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2026 PRAC
 New
03/08/2026
Document: European Union Member State Public Holidays Recorded in CTIS (year: 2027)
 New
03/08/2026
Medicine: Svariya (previously Rivaroxaban Koanaa) rivaroxaban
Updated
03/08/2026
Event: Enpr-EMA Coordinating Group meeting June 2026
 New
03/08/2026
Document: PRAC recommendations on signals adopted at the 6-9 July 2026 PRAC meeting
 New
03/08/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
03/08/2026
Document: Breakthrough status request: Template for applicants for breakthrough medical devices pilot
 Updated
03/08/2026
Event: European platform for regulatory science research meeting: October 2026
 New
03/08/2026
Event: Fifth European Medicines Agency (EMA) and Affordable Medicines Europe bilateral meeting
 New
03/08/2026
Event: Ninth European Medicines Agency (EMA) and EFPIA bilateral meeting
 New
03/08/2026
Page: Veterinary Medicines
 Updated
03/08/2026
Document: Organisation chart: Veterinary Medicines
 Updated
03/08/2026
Document: Organisation chart: Advisory functions
 Updated