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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
25/11/2025
Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs)
 Updated
25/11/2025
Medicine: Accofil filgrastim
Updated
25/11/2025
Medicine: Erelzi etanercept
Updated
25/11/2025
Medicine: Minjuvi tafasitamab
Updated
25/11/2025
Medicine: Zynlonta loncastuximab tesirine
Updated
25/11/2025
Document: Scientific recommendations on classification of advanced therapy medicinal products
 Updated
25/11/2025
Event: EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation
 Updated
25/11/2025
Document: Minutes of the COMP meeting 7-8 October 2025
 New
25/11/2025
Document: Step-by-step guide: How to evaluate a CT application - CTIS Training Programme - Module 06
 Updated
25/11/2025
Document: European Medicines Agency’s data protection notice for PMS user acceptance stakeholder involvement
 New
25/11/2025
Medicine: Pedea ibuprofen
Updated
25/11/2025
Page: Website outages and upgrades
 Updated
24/11/2025
Medicine: Brukinsa zanubrutinib
Updated
24/11/2025
Medicine: Sirturo bedaquiline
Updated
24/11/2025
Medicine: Cetrotide cetrorelix
Updated
24/11/2025
Medicine: Lupkynis voclosporin
Updated
24/11/2025
Medicine: Opdualag relatlimab; nivolumab
Updated
24/11/2025
Medicine: SonoVue sulphur hexafluoride
Updated
24/11/2025
Medicine: Reblozyl luspatercept
Updated
24/11/2025
Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine
Updated
24/11/2025
Medicine: Nyvepria pegfilgrastim
Updated
24/11/2025
Document: Agenda of the PRAC meeting 24 - 27 November 2025
 New
24/11/2025
Medicine: Siklos hydroxycarbamide
Updated
24/11/2025
Medicine: Crysvita burosumab
Updated
24/11/2025
Medicine: Pradaxa dabigatran etexilate
Updated
24/11/2025
Medicine: Hizentra human normal immunoglobulin (SCIg)
Updated
24/11/2025
PSUSA: PSUSA/00002510/202501 - periodic safety update report single assessment prednisone
New
24/11/2025
Medicine: Xermelo telotristat ethyl
Updated
24/11/2025
Medicine: Denbrayce denosumab
Updated
24/11/2025
Medicine: Ebvallo tabelecleucel
Updated
24/11/2025
Medicine: Mayzent siponimod
Updated
24/11/2025
Page: PRAC recommendations on safety signals
 Updated
24/11/2025
Document: List of signals discussed at PRAC since September 2012
 Updated
24/11/2025
Document: PRAC recommendations on signals adopted at the 27-30 October 2025 PRAC meeting
 New
24/11/2025
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 27-30 October 2025 PRAC
 New
24/11/2025
PSUSA: PSUSA/00003045/202501 - periodic safety update report single assessment trimethoprim
New
21/11/2025
Page: Organisation Management Service (OMS)
 Updated
21/11/2025
Page: Referentials Management Service (RMS)
 Updated
21/11/2025
Page: Vaccines: concerns, questions and false claims
 New
21/11/2025
Medicine: Steglujan ertugliflozin; sitagliptin
Updated
21/11/2025
Medicine: Steglatro ertugliflozin
Updated
21/11/2025
Medicine: Segluromet ertugliflozin; metformin hydrochloride
Updated
21/11/2025
Medicine: Invanz ertapenem
Updated
21/11/2025
Medicine: Obizur susoctocog alfa
Updated
21/11/2025
Page: PRIME: priority medicines
 Updated
21/11/2025
Medicine: Yervoy ipilimumab
Updated
21/11/2025
Document: List of medicines currently in PRIME scheme
 Updated
21/11/2025
Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 10-13 November 2025
 New
21/11/2025
Medicine: Vimpat lacosamide
Updated
21/11/2025
Medicine: Opdivo nivolumab
Updated
21/11/2025
Event: Quarterly System Demo - Q4 2025
 Updated
21/11/2025
Medicine: Neuraceq florbetaben (18F)
Updated
21/11/2025
Medicine: Pyzchiva ustekinumab
Updated
21/11/2025
Medicine: Eiyzey aflibercept
Updated
21/11/2025
Medicine: Yselty linzagolix choline
Updated
21/11/2025
Document: Regulatory Procedure Management in IRIS roadmap
 New
21/11/2025
Document: Minutes of the PRAC meeting 29 September - 2 October 2025
 New
21/11/2025
Document: Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 October 2025
 New
21/11/2025
Event: Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease
 Updated
21/11/2025
Document: Minutes of the HMPC meeting 22-24 September 2025
 New
21/11/2025
Page: Antimicrobial resistance
 Updated
21/11/2025
Document: Antimicrobial resistance – Act Now: Protect our present, secure our future
 New
21/11/2025
Page: International Coalition of Medicines Regulatory Authorities (ICMRA)
 Updated
21/11/2025
Medicine: Usgena ustekinumab
Updated
20/11/2025
Medicine: Afinitor everolimus
Updated
20/11/2025
Page: Download website data in JSON data format
 Updated
20/11/2025
Medicine: Votubia everolimus
Updated
20/11/2025
Medicine: Maviret glecaprevir; pibrentasvir
Updated
20/11/2025
Medicine: Izamby denosumab
Updated
20/11/2025
Medicine: Tecartus brexucabtagene autoleucel
Updated
20/11/2025
Medicine: Xydalba dalbavancin
Updated
20/11/2025
Medicine: Atectura Breezhaler indacaterol; mometasone
Updated
20/11/2025
Medicine: Enerzair Breezhaler indacaterol; glycopyrronium bromide; mometasone
Updated
20/11/2025
News: Call for expressions of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee
 New
20/11/2025
Medicine: Gobivaz golimumab
Updated
20/11/2025
Shortage: ADHD medicines atomoxetine; methylphenidate; lisdexamfetamine
Updated
20/11/2025
Page: Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)
 Updated
20/11/2025
PIP: EMEA-003153-PIP01-21 - paediatric investigation plan HIV-1 Maturation Inhibitor (GSK3640254)
Updated
20/11/2025
Medicine: Teizeild teplizumab
Updated
20/11/2025
News: First-in-class treatment to delay onset of type 1 diabetes
 Updated
19/11/2025
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
19/11/2025
Medicine: Erleada apalutamide
Updated
19/11/2025
Medicine: Dafiro amlodipine; valsartan
Updated
19/11/2025
Event: HMA/EMA multi-stakeholder workshop on artificial intelligence (AI)
 Updated
19/11/2025
Medicine: Copalia amlodipine; valsartan
Updated
19/11/2025
Medicine: Exforge amlodipine; valsartan
Updated
19/11/2025
Shortage: Risperidone risperidone
New
19/11/2025
Medicine: Remsima infliximab
Updated
19/11/2025
Page: Search tips
 Updated
19/11/2025
Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)
Updated
19/11/2025
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
19/11/2025
Medicine: Synjardy empagliflozin; metformin
Updated
19/11/2025
Medicine: Sogroya somapacitan
Updated
19/11/2025
Document: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2025
 New
19/11/2025
Medicine: Shingrix herpes zoster vaccine (recombinant, adjuvanted)
Updated
19/11/2025
Medicine: Descovy emtricitabine; tenofovir alafenamide
Updated
18/11/2025
Page: Medicines for human use under evaluation
 Updated
18/11/2025
Document: Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)
 New
18/11/2025
Document: Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)
 New
18/11/2025
Medicine: Viread tenofovir disoproxil
Updated
18/11/2025
Medicine: Hirobriz Breezhaler indacaterol
Updated
18/11/2025
Medicine: Oslif Breezhaler indacaterol
Updated
18/11/2025
Medicine: Onbrez Breezhaler indacaterol
Updated
18/11/2025
Event: Workshop on the use of external controls for evidence generation in regulatory decision-making
 Updated
18/11/2025
Medicine: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz; emtricitabine; tenofovir disoproxil
Updated
18/11/2025
Medicine: Prevenar 20 (previously Apexxnar) pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Updated
18/11/2025
Event: Medicine shortages: EMA public webinar putting patients first
 Updated
18/11/2025
Event: EMA workshop: Non-clinical data for regulatory decision-making on the efficacy of medical countermeasures
 Updated
18/11/2025
Medicine: Inhixa enoxaparin sodium
Updated
18/11/2025
Page: Podcast: Inside EMA
 New
18/11/2025
Medicine: Truvada emtricitabine; tenofovir disoproxil
Updated
18/11/2025
Medicine: Vizamyl flutemetamol (18F)
Updated
18/11/2025
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 10-13 November 2025
 New
18/11/2025
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 13-16 October 2025
 New
18/11/2025
PSUSA: PSUSA/00002735/202501 - periodic safety update report single assessment sodium citrate / sodium lauryl sulfoacetate, sodium citrate / sodium lauryl sulfoacetate / sorbitol
New
18/11/2025
Medicine: Omlyclo omalizumab
Updated
18/11/2025
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 15-18 September 2025
 New
18/11/2025
Medicine: Voxzogo vosoritide
Updated
18/11/2025
Medicine: Absimky ustekinumab
Updated
18/11/2025
Event: Fifth Veterinary Big Data Stakeholder Forum
 Updated
18/11/2025
Page: EMA's work on public health emergencies
 Updated
18/11/2025
Document: EMA health threats plan - Annex 1: Acceleration of regulatory procedures during public health emergencies
 New
18/11/2025
Document: EMA health threats plan
 Updated
18/11/2025
Medicine: Enwylma denosumab
Updated
18/11/2025
Medicine: Effentora fentanyl
Updated
18/11/2025
Medicine: Tecentriq atezolizumab
Updated
18/11/2025
Medicine: Ozawade pitolisant
Updated
18/11/2025
Event: EMA - European Consumer Organisation (BEUC) bilateral meeting
 New
18/11/2025
Document: Dates of 2025 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests
 Updated
18/11/2025
Document: Dates of 2026 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests
 Updated
17/11/2025
Page: ICH E2D post-approval safety data management - scientific guideline
 Updated
17/11/2025
Medicine: Ristfor sitagliptin; metformin hydrochloride
Updated
17/11/2025
PIP: EMEA-001489-PIP02-19 - paediatric investigation plan Idasanutlin
Updated
17/11/2025
PIP: EMEA-001489-PIP01-13-M02 - paediatric investigation plan Idasanutlin
Updated
17/11/2025
PIP: EMEA-002821-PIP01-20 - paediatric investigation plan Respiratory Syncytial Virus PreF3 recombinant fusion protein (RSVPreF3)
Updated
17/11/2025
PIP: EMEA-002475-PIP04-23 - paediatric investigation plan spesolimab
Updated
17/11/2025
Medicine: Awiqli insulin icodec
Updated
17/11/2025
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – November 2025
 Updated
17/11/2025
Document: Agenda of the HMPC meeting 17-19 November 2025
 New
17/11/2025
Medicine: Odomzo sonidegib
Updated
17/11/2025
Document: Medicinal products for human use: monthly figures - October 2025
 New
17/11/2025
Medicine: Isentress raltegravir
Updated
17/11/2025
Medicine: Loargys pegzilarginase
Updated
17/11/2025
Medicine: Ivabradine Anpharm ivabradine
Updated
17/11/2025
News: Improved scientific advice for medicines for public health threats including antimicrobial resistance
 New
17/11/2025
Page: Emergency Task Force (ETF)
 Updated
17/11/2025
Page: Emergency Task Force (ETF) recommendations
 Updated
17/11/2025
Page: Scientific advice and protocol assistance
 Updated
17/11/2025
Page: Parallel scientific advice and special development aspects or product types
 Updated
17/11/2025
Page: Clinical trials in human medicines
 Updated
17/11/2025
Page: Scientific advice for public health emergencies and threats
 New
17/11/2025
Document: Guidance for applicants: the ETF scientific advice that facilitates clinical trial authorisations (SA-CTA)
 New
17/11/2025
Medicine: Corlentor ivabradine
Updated
17/11/2025
Medicine: Procoralan ivabradine
Updated
17/11/2025
Medicine: Rinvoq upadacitinib
Updated
17/11/2025
Medicine: Imreplys sargramostim
Updated
17/11/2025
Page: Task Forces
 Updated
17/11/2025
Document: Severe cutaneous adverse reactions - standard template wording for product information
 New
17/11/2025
Medicine: Ebglyss lebrikizumab
Updated
14/11/2025
PIP: EMEA-002554-PIP02-19 - paediatric investigation plan cilofexor
Updated
14/11/2025
PIP: EMEA-003521-PIP01-23 - paediatric investigation plan single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)
Updated
14/11/2025
Referral: Ipidacrine-containing medicinal products - referral ipidacrine
Updated
14/11/2025
Medicine: Anagrelide Viatris (previously Anagrelide Mylan) anagrelide
Updated
14/11/2025
Medicine: Tukysa tucatinib
Updated
14/11/2025
Medicine: Elucirem gadopiclenol
Updated
14/11/2025
Medicine: Ondexxya andexanet alfa
Updated
14/11/2025
Medicine: Plegridy peginterferon beta-1a
Updated
14/11/2025
Page: Veterinary limited markets
 Updated
14/11/2025
Page: Incident management plan
 Updated
14/11/2025
Medicine: Ranivisio ranibizumab
Updated
14/11/2025
Medicine: Epruvy (previously Ranibizumab Midas) ranibizumab
Updated
14/11/2025
Event: PMS Product user interface (PUI) Training: Product data submission & bulk edit made easy
 Updated
14/11/2025
Medicine: Kizfizo temozolomide
Updated
14/11/2025
Event: European Medicine Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting
 Updated
14/11/2025
Medicine: Alyftrek deutivacaftor / tezacaftor / vanzacaftor
Updated
14/11/2025
Referral: Tecovirimat SIGA - referral tecovirimat
Updated
14/11/2025
Medicine: Tysabri natalizumab
Updated
14/11/2025
Event: European Medicines Agency (EMA) and European Association of Urology (EAU) bilateral meeting
 Updated
14/11/2025
Medicine: Enflonsia clesrovimab
Updated
14/11/2025
Medicine: Ohtuvayre ensifentrine
New
14/11/2025
Medicine: Insulin Aspart Injection insulin aspart
New
14/11/2025
Medicine: Nurzigma pridopidine
Updated
14/11/2025
Post-authorisation: Xerava - opinion on variation to marketing authorisation eravacycline
New
14/11/2025
Medicine: Dawnzera donidalorsen
New
14/11/2025
Medicine: Ondibta insulin glargine
New
14/11/2025
Medicine: GalenVita germanium (68Ge) chloride; gallium (68Ga) chloride
New
14/11/2025
Medicine: Osqay denosumab
New
14/11/2025
Medicine: VacPertagen pertussis vaccine (recombinant, acellular, component, adsorbed)
New
14/11/2025
Medicine: Aqneursa L-acetylleucine
Updated
14/11/2025
Medicine: Teduglutide Viatris teduglutide
New
14/11/2025
Medicine: Waskyra autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein
New
14/11/2025
Medicine: Inluriyo imlunestrant
New
14/11/2025
Medicine: Rezurock Belumosudil
Updated
14/11/2025
Medicine: Enzalutamide Accordpharma enzalutamide
New
14/11/2025
Medicine: Hetlioz tasimelteon
Updated
14/11/2025
News: First gene therapy to treat rare disease Wiskott-Aldrich syndrome
 New
14/11/2025
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025
 New
14/11/2025
Post-authorisation: Veyvondi - opinion on variation to marketing authorisation vonicog alfa
New
14/11/2025
Post-authorisation: Minjuvi - opinion on variation to marketing authorisation tafasitamab
New
14/11/2025
Post-authorisation: Koselugo - opinion on variation to marketing authorisation selumetinib
New
14/11/2025
Medicine: Juluca dolutegravir; rilpivirine
Updated
14/11/2025
Medicine: Dovato dolutegravir; lamivudine
Updated
14/11/2025
Event: European Medicines Agency and Transcelerate bilateral meeting
 New
14/11/2025
Medicine: Zypadhera olanzapine
Updated
14/11/2025
Medicine: Tivicay dolutegravir
Updated
14/11/2025
Medicine: Triumeq abacavir; dolutegravir; lamivudine
Updated
14/11/2025
Page: Medicine shortage communications (MSC)
 Updated
14/11/2025
Shortage: Bronchitol mannitol
New
14/11/2025
Document: Medicine shortage communication (MSC) : Bronchitol, 40 mg inhalation powder, hard capsules: ongoing shortage
 New
14/11/2025
Page: Substance and product data management services
 Updated
14/11/2025
Medicine: Zavicefta ceftazidime; avibactam
Updated
14/11/2025
Document: Minutes of the CVMP meeting 7-9 October 2025
 New
14/11/2025
Page: Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species - Scientific guideline
 New
14/11/2025
Document: Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species
 New
14/11/2025
Document: Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)
 New
14/11/2025
Document: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
 Updated
13/11/2025
PIP: EMEA-002815-PIP01-20 - paediatric investigation plan rozibafusp alfa
Updated
13/11/2025
Medicine: Mekinist trametinib
Updated
13/11/2025
Medicine: Afiveg aflibercept
Updated
13/11/2025
Medicine: Hefiya adalimumab
Updated
13/11/2025
Medicine: Hyrimoz adalimumab
Updated
13/11/2025
Page: ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline
 Updated
13/11/2025
Document: Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
 Updated
13/11/2025
Document: Concept paper on a paediatric update of the guideline on clinical investigation of medicinal products for the management of Crohn’s disease
 Updated
13/11/2025
Document: Concept paper on a paediatric update on the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis
 Updated
13/11/2025
PIP: EMEA-003156-PIP02-22 - paediatric investigation plan Efavaleukin alfa
Updated
13/11/2025
Document: Records of data processing activity for internal publication of appointments, transfers and departures
 New
13/11/2025
Medicine: Sitagliptin / Metformin hydrochloride Accord sitagliptin; metformin hydrochloride
Updated
13/11/2025
Medicine: Dasatinib Accord Healthcare dasatinib
Updated
13/11/2025
Medicine: Efient prasugrel
Updated
13/11/2025
Document: European medicines regulatory network incident management plan for medicines for human use
Updated
13/11/2025
Document: Draft guideline on non-inferiority and equivalence comparisons in clinical trials
 New
13/11/2025
Page: Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline
 New
13/11/2025
Page: Switching between superiority and non-inferiority - Scientific guideline
 Updated
13/11/2025
Page: Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline
 Updated
13/11/2025
Medicine: Janumet sitagliptin; metformin
Updated
13/11/2025
Document: Records of data processing activity for workstation ergonomics in the context of Health & Safety of staff and contractors
 Updated
12/11/2025
PSUSA: PSUSA/00009145/202412 - periodic safety update report single assessment estradiol (17-beta) / progesterone
New
12/11/2025
Medicine: Tevimbra tislelizumab
Updated
12/11/2025
Medicine: Kisqali ribociclib
Updated
12/11/2025
Medicine: Lutathera lutetium (177Lu) oxodotreotide
Updated
12/11/2025
Medicine: Iclusig ponatinib
Updated
12/11/2025
Medicine: Kaftrio ivacaftor; tezacaftor; elexacaftor
Updated
12/11/2025
Medicine: Eyluxvi aflibercept
Updated
12/11/2025
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
12/11/2025
Medicine: Glivec imatinib
Updated
12/11/2025
Document: EVVet3 EVWeb Production - Release notes
 Updated
12/11/2025
Document: List of eligible industry stakeholder organisations
 Updated
12/11/2025
Event: Fourth European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting
 New
12/11/2025
Event: Fourth European Medicines Agency - Medtech Europe bilateral meeting
 Updated
12/11/2025
Document: Highlights – Fourth EMA-Vaccines Europe bilateral meeting
 New
11/11/2025
Document: Faecal microbiota transplantation EU-IN Horizon Scanning Report
 Updated
11/11/2025
Medicine: Datopotamab deruxtecan Daiichi Sankyo datopotamab deruxtecan
Updated
11/11/2025
Medicine: Slenyto melatonin
Updated
11/11/2025
Medicine: Uzpruvo ustekinumab
Updated
11/11/2025
Document: Agenda - PCWP/HCPWP and all eligible organisations meeting 2025
 Updated
11/11/2025
Medicine: Norvir ritonavir
Updated
11/11/2025
Medicine: Roctavian valoctocogene roxaparvovec
Updated
11/11/2025
Shortage: Beriglobin human normal immunoglobulin
New
11/11/2025
Document: Medicine shortage communication (MSC) : Beriglobin (human normal immunoglobulin), 2 mL and 5 mL solution for injection in pre-filled syringe: supply shortage and cessation of marketing (discontinuation)
 New
11/11/2025
Medicine: mResvia Respiratory syncytial virus mRNA vaccine (nucleoside modified)
Updated
11/11/2025
Document: Article 57 product data
 Updated
11/11/2025
Document: Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report
 Updated
11/11/2025
Document: Nanotechnology-based medicinal products for human use EU-IN Horizon Scanning Report
 Updated
11/11/2025
Event: Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025
 Updated
11/11/2025
Event: ACT EU multi-stakeholder platform annual meeting
 Updated
11/11/2025
Page: Eligible patients and consumers organisations
 Updated
11/11/2025
Document: Agenda - PDCO agenda of the 11-14 November 2025 meeting
 New
10/11/2025
PIP: EMEA-002713-PIP02-21-M02 - paediatric investigation plan etrasimod
Updated
10/11/2025
PIP: EMEA-003152-PIP01-21 - paediatric investigation plan dolutegravir; HIV-1 Maturation Inhibitor (GSK3640254)
Updated
10/11/2025
PIP: EMA/PE/0000246904 - paediatric investigation plan cobolimab
Updated
10/11/2025
Medicine: Jakavi ruxolitinib
Updated
10/11/2025
Medicine: Verquvo vericiguat
Updated
10/11/2025
Medicine: Tecovirimat SIGA tecovirimat monohydrate
Updated
10/11/2025
Medicine: Nemluvio nemolizumab
Updated
10/11/2025
Medicine: Sitagliptin SUN sitagliptin fumarate
Updated
10/11/2025
Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2025
 Updated
10/11/2025
Medicine: Aspaveli pegcetacoplan
Updated
10/11/2025
DHPC: Libtayo - direct healthcare professional communication (DHPC) cemiplimab
Updated
10/11/2025
Medicine: Flixabi infliximab
Updated
10/11/2025
Document: Agenda - HMA/EMA Annual Data Forum 2025
 Updated
10/11/2025
Page: Quality of medicines questions and answers: Part 1
 Updated
10/11/2025
Medicine: Dectova zanamivir
Updated
10/11/2025
Document: Annex to agenda of the CHMP meeting 10-13 November 2025
 New
10/11/2025
Document: Agenda of the CHMP meeting 10-13 November 2025
 New
10/11/2025
Medicine: Oyavas bevacizumab
Updated
10/11/2025
Medicine: Rezdiffra resmetirom
Updated
10/11/2025
Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025
 Updated
07/11/2025
Medicine: HBVaxPro hepatitis B vaccine (recombinant DNA)
Updated
07/11/2025
Document: MSSG Voluntary Solidarity Mechanism
 Updated
07/11/2025
Medicine: Baiama aflibercept
Updated
07/11/2025
Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)
 Updated
07/11/2025
Medicine: Ahzantive aflibercept
Updated
07/11/2025
Orphan: EU/3/15/1504 - orphan designation for treatment of follicular lymphoma obinutuzumab
Updated
07/11/2025
Medicine: Gazyvaro obinutuzumab
Updated
07/11/2025
Medicine: Ecovaxxin MS Mycoplasma synoviae, strain K588A, Live
New
07/11/2025
Medicine: Vaxxinact H5 Avian influenza virus, subtype H5, haemagglutinin (recombinant)
New
07/11/2025
News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 2025
 New
07/11/2025
Post-authorisation: Mhyosphere PCV ID - opinion on variation to marketing authorisation Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)
New
07/11/2025
Post-authorisation: Credelio - opinion on variation to marketing authorisation lotilaner
New
07/11/2025
Post-authorisation: Dupixent - withdrawal of application for variation to marketing authorisation dupilumab
Updated
07/11/2025
Post-authorisation: Frontpro (previously Afoxolaner Merial) - opinion on variation to marketing authorisation afoxolaner
New
07/11/2025
Page: Cancer medicines
 Updated
07/11/2025
Page: Personalised medicine in oncology
 New
07/11/2025
Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23
 Updated
07/11/2025
Page: Union Product Database: release notes
 Updated
07/11/2025
Document: Release notes - production release version 1.7.2541 - 7 November 2025 - Veterinary Medicinal Products Regulation: Union Product Database
 New
07/11/2025
Document: Clinical Trial Information System (CTIS) - Sponsor handbook
 Updated
07/11/2025
Medicine: Cubicin daptomycin
Updated
07/11/2025
Medicine: Zepatier elbasvir; grazoprevir
Updated
07/11/2025
Medicine: Yesintek ustekinumab
Updated
07/11/2025
Medicine: Fingolimod Mylan fingolimod
Updated
07/11/2025
Medicine: Zoledronic acid Mylan zoledronic acid
Updated
06/11/2025
Medicine: Bridion sugammadex
Updated
06/11/2025
Medicine: Mysimba naltrexone; bupropion
Updated
06/11/2025
Medicine: Temodal temozolomide
Updated
06/11/2025
Referral: Veterinary medicinal products containing amoxicillin - referral amoxicillin
New
06/11/2025
Medicine: Quadramet samarium [153Sm] lexidronam pentasodium
Updated
06/11/2025
Medicine: Entecavir Viatris (previously Entecavir Mylan) entecavir
Updated
06/11/2025
Medicine: Duavive oestrogens conjugated; bazedoxifene
Updated
06/11/2025
Medicine: Lenalidomide Mylan lenalidomide
Updated
06/11/2025
Medicine: Revolade eltrombopag
Updated
06/11/2025
Medicine: Kymriah tisagenlecleucel
Updated
06/11/2025
Medicine: Ervebo Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live)
Updated
06/11/2025
Medicine: Increlex mecasermin
Updated
06/11/2025
Medicine: Mounjaro tirzepatide
Updated
06/11/2025
Page: Safety of medicines
 New
06/11/2025
Page: What we do
 Updated
06/11/2025
Document: From laboratory to patients: How the safety of medicines is ensured in the Europen Union
 New
06/11/2025
PIP: EMA/PE/0000232853 - paediatric investigation plan nitrosomonas eutropha, strain D23, live
New
06/11/2025
PIP: EMEA-003288-PIP01-22 - paediatric investigation plan bexicaserin
New
06/11/2025
PIP: EMA/PE/0000231113 - paediatric investigation plan nemvaleukin alfa
Updated
06/11/2025
PIP: EMA/PE/0000257243 - paediatric investigation plan pozelimab
Updated
06/11/2025
Medicine: Xoanacyl ferric citrate coordination complex
Updated
05/11/2025
Medicine: Pregabalin Viatris Pharma (previously Pregabalin Pfizer) pregabalin
Updated
05/11/2025
Medicine: Rivaroxaban Viatris (previously Rivaroxaban Mylan) rivaroxaban
Updated
05/11/2025
PSUSA: PSUSA/00000426/202412 - periodic safety update report single assessment botulinum toxin a (except for centrally authorised products)
New
05/11/2025
PSUSA: PSUSA/00000109/202503 - periodic safety update report single assessment alprazolam
New
05/11/2025
PSUSA: PSUSA/00000799/202502 - periodic safety update report single assessment clobetasol
New
05/11/2025
PSUSA: PSUSA/00000886/202503 - periodic safety update report single assessment cyamemazine
New
05/11/2025
PSUSA: PSUSA/00001317/202503 - periodic safety update report single assessment ethyl loflazepate
New
05/11/2025
PSUSA: PSUSA/00001466/202503 - periodic safety update report single assessment fomepizole
New
05/11/2025
Medicine: Usymro ustekinumab
Updated
05/11/2025
Medicine: Pylclari piflufolastat (18F)
Updated
05/11/2025
Medicine: Pegasys peginterferon alfa-2a
Updated
05/11/2025
Medicine: Beyonttra acoramidis
Updated
05/11/2025
Medicine: Portela relfovetmab
Updated
05/11/2025
Medicine: Grasustek pegfilgrastim
Updated
05/11/2025
Medicine: Mektovi binimetinib
Updated
05/11/2025
Medicine: Braftovi encorafenib
Updated
05/11/2025
Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services
 Updated
05/11/2025
Medicine: Ivemend fosaprepitant
Updated
05/11/2025
Document: European Medicines Agency Write PMS API implementation Guide
 Updated
05/11/2025
Page: Guidelines Consistency Group
 Updated
05/11/2025
Document: Applications for new human medicines under evaluation: November 2025
 New
05/11/2025
Medicine: Erivedge vismodegib
Updated
05/11/2025
Document: Minutes - PDCO minutes of the 9-12 September 2025 meeting
 New
04/11/2025
Event: 15th industry stakeholder platform on research and development support
 New
04/11/2025
Medicine: Rekambys rilpivirine
Updated
04/11/2025
Medicine: Jivi damoctocog alfa pegol
Updated
04/11/2025
Medicine: Finlee dabrafenib
Updated
04/11/2025
Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP
 Updated
04/11/2025
Document: Minutes of the PRAC meeting 2-5 June 2025
 Updated
04/11/2025
Event: Committee for Advanced Therapies (CAT): 5-7 November 2025
 Updated
04/11/2025
Document: Minutes of the PRAC meeting 7-10 July 2025
 Updated
04/11/2025
Page: Good pharmacovigilance practices (GVP)
 Updated
04/11/2025
Document: Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568
 Updated
04/11/2025
Document: Adzynma : EPAR - Public assessment report
 Updated
04/11/2025
Page: Combination Products Operational Group
 New
04/11/2025
Page: Combination Products Operational Group: agendas and minutes
 New
04/11/2025
Page: Medical devices
 Updated
04/11/2025
Medicine: Tuzulby methylphenidate hydrochloride
Updated
04/11/2025
Document: QRD Form 2 and checklist for the submission of day +25 files - human
 Updated
04/11/2025
Document: QRD Form 2 and checklist for the submission of day +25 files - veterinary
 Updated
04/11/2025
Document: Member states contact points for translations review
 Updated
04/11/2025
Document: Member states contact points for review of national versions of the content of mobile scanning and other technologies
 Updated
04/11/2025
Document: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
 Updated
04/11/2025
Document: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
 Updated
04/11/2025
Document: Abbreviation of names of days on calendarised blisters
 Updated
04/11/2025
Medicine: Truqap capivasertib
Updated
04/11/2025
PSUSA: PSUSA/00001029/202503 - periodic safety update report single assessment diazepam
New
04/11/2025
PSUSA: PSUSA/00010808/202503 - periodic safety update report single assessment erythromycin (systemic use)
New
04/11/2025
Medicine: Tremfya guselkumab
Updated
04/11/2025
Document: Agenda - 1st EMA and European Respiratory Society (ERS) bilateral meeting
 New
04/11/2025
Medicine: Piqray alpelisib
Updated
04/11/2025
Medicine: Tafinlar dabrafenib
Updated
04/11/2025
Medicine: Vgenfli aflibercept
Updated
04/11/2025
Page: Fighting medicine shortages: It takes a team
 New
04/11/2025
Page: Medicine shortages and availability issues
 Updated
04/11/2025
News: EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign
New
04/11/2025
Medicine: Bravecto TriUNO fluralaner; moxidectin; pyrantel
Updated
03/11/2025
Document: Advice to medical device manufacturers - 2026 Timetable
 New
03/11/2025
PSUSA: PSUSA/00001597/202502 - periodic safety update report single assessment hepatitis B vaccine (rDNA)
New
03/11/2025
PSUSA: PSUSA/00000461/202412 - periodic safety update report single assessment bupropion
New
03/11/2025
Medicine: Spexotras trametinib
Updated
03/11/2025
Document: Agenda of the CVMP meeting 4-6 November 2025
 New
03/11/2025
Document: Meeting Summary - Medicine Shortages (SPOC) Working Party 10 September 2025
 New
03/11/2025
Medicine: Xromi hydroxycarbamide
Updated
03/11/2025
Medicine: Myalepta metreleptin
Updated
03/11/2025
Document: Agenda of the COMP meeting 4-6 November 2025
 New
03/11/2025
Document: Policy 46: European Medicines Agency policy on video surveillance
 Updated
03/11/2025
Page: CHMP opinions on consultation procedures
 Updated
03/11/2025
Document: Consultation on an ancillary medicinal substance incorporated in a medical device - XVIVO Heart Solution
 New
03/11/2025
Shortage: Eldisine vindesine
Updated
03/11/2025
Document: Records of data processing activity for Early Notification System (ENS)
 New
03/11/2025
Document: European Medicine Agency's data protection notice for the Interactive Regulatory Information System (IRIS)
 Updated
03/11/2025
Page: One Health approach
 Updated