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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 (249)

Date Content Status
16/06/2026
PSUSA: PSUSA/00001104/202509 - periodic safety update report single assessment dinoprostone
New
16/06/2026
Document: Regulatory Procedure Management in IRIS roadmap
 Updated
16/06/2026
PSUSA: PSUSA/00010155/202509 - periodic safety update report single assessment felbamate
New
16/06/2026
Page: Frequently asked questions
 Updated
16/06/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
16/06/2026
PSUSA: PSUSA/00002305/202511 - periodic safety update report single assessment ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine
New
16/06/2026
PSUSA: PSUSA/00000767/202511 - periodic safety update report single assessment cinnarizine / dimenhydrinate
New
16/06/2026
PSUSA: PSUSA/00000694/202511 - periodic safety update report single assessment acetylsalicylic acid / chlorphenamine / phenylephrine
New
16/06/2026
Event: First Advisory group on vaccine confidence meeting
 New
16/06/2026
PSUSA: PSUSA/00002564/202510 - periodic safety update report single assessment prothipendyl
Updated
16/06/2026
Medicine: Eydenzelt aflibercept
Updated
16/06/2026
Medicine: Kefdensis denosumab
Updated
16/06/2026
Document: Process for the electronic submission of medicinal product information - Chapter 3
 Updated
16/06/2026
Event: Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease
 Updated
16/06/2026
Document: Committee for Advanced Therapies (CAT) rules of procedure
 Updated
16/06/2026
PSUSA: PSUSA/00000967/202509 - periodic safety update report single assessment desogestrel / ethinylestradiol
New
16/06/2026
PSUSA: PSUSA/00001786/202510 - periodic safety update report single assessment isoflurane
New
16/06/2026
PSUSA: PSUSA/00010735/202510 - periodic safety update report single assessment valsartan / rosuvastatin
New
16/06/2026
PSUSA: PSUSA/00000236/202510 - periodic safety update report single assessment artemether / lumefantrin (apart from the dispersible tablet)
New
16/06/2026
PSUSA: PSUSA/00000165/202510 - periodic safety update report single assessment aminosalicylic acid
New
16/06/2026
PSUSA: PSUSA/00000437/202509 - periodic safety update report single assessment bromhexine
New
16/06/2026
PSUSA: PSUSA/00000794/202509 - periodic safety update report single assessment clenbuterol
New
16/06/2026
PSUSA: PSUSA/00002681/202510 - periodic safety update report single assessment salmeterol
New
16/06/2026
PSUSA: PSUSA/00002066/202510 - periodic safety update report single assessment minoxidil (non topical formulations)
New
16/06/2026
Medicine: Kadcyla trastuzumab emtansine
Updated
16/06/2026
Medicine: Nucala mepolizumab
Updated
16/06/2026
Medicine: Ziihera zanidatamab
Updated
15/06/2026
Medicine: Startvac adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci
Updated
15/06/2026
Medicine: Lonquex lipegfilgrastim
Updated
15/06/2026
Medicine: Opzelura ruxolitinib
Updated
15/06/2026
Medicine: Palsonify paltusotine
Updated
15/06/2026
Medicine: Entyvio vedolizumab
Updated
15/06/2026
Medicine: Rimmyrah ranibizumab
Updated
15/06/2026
Medicine: Rezzayo rezafungin
Updated
15/06/2026
Medicine: Zolgensma onasemnogene abeparvovec
Updated
15/06/2026
Medicine: Grasustek pegfilgrastim
Updated
15/06/2026
Page: Contacting EMA: post-authorisation
 Updated
15/06/2026
Page: Notifying EMA of changes to contact persons (veterinary medicines)
 Updated
15/06/2026
Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants
 Updated
15/06/2026
Document: IRIS guide to registration and RPIs
 Updated
15/06/2026
Referral: Tecovirimat SIGA - referral tecovirimat
Updated
15/06/2026
Medicine: Tecovirimat SIGA tecovirimat monohydrate
Updated
15/06/2026
Event: Webinar on the use of platform approaches in the non-clinical and clinical domains
 Updated
15/06/2026
Event: Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2026
 Updated
15/06/2026
News: EMA Management Board: highlights of June 2026 meeting
 New
15/06/2026
Medicine: Sitagliptin / Metformin hydrochloride Mylan sitagliptin hydrochloride monohydrate; metformin hydrochloride
Updated
15/06/2026
Medicine: Tadalafil Mylan tadalafil
Updated
15/06/2026
Medicine: Tuyory tocilizumab
Updated
12/06/2026
Medicine: Zutectra human hepatitis B immunoglobulin
Updated
12/06/2026
Medicine: Emtricitabine/Tenofovir disoproxil Mylan emtricitabine; tenofovir disoproxil
Updated
12/06/2026
Document: Lonquex : EPAR - Public assessment report
 Updated
12/06/2026
Medicine: Dimethyl fumarate Mylan dimethyl fumarate
Updated
12/06/2026
Medicine: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz; emtricitabine; tenofovir disoproxil
Updated
12/06/2026
Document: Products Management Services (PMS) public API - Terms and conditions
 New
12/06/2026
Medicine: Sugammadex Mylan sugammadex
Updated
12/06/2026
Medicine: Lenalidomide Mylan lenalidomide
Updated
12/06/2026
Medicine: Fulvestrant Mylan fulvestrant
Updated
12/06/2026
Event: Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop
 New
12/06/2026
Document: Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda
 New
12/06/2026
Document: Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for Identification of Medicinal Products (IDMP) in Europe: Registration requirements to public PMS API (beta release) - Chapter 1, Annex B
 New
12/06/2026
Document: Product Management Service (PMS) User Acceptance Testing (UAT) Application Programming Interface (API) registration process for industry - Chapter 1, Annex A
 Updated
12/06/2026
Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements for production environments
 Updated
12/06/2026
Page: Substance and product data management services
 Updated
12/06/2026
Medicine: Amlodipine / Valsartan Mylan amlodipine; valsartan
Updated
12/06/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
 New
12/06/2026
Medicine: Fingolimod Mylan fingolimod
Updated
12/06/2026
Medicine: Deferasirox Mylan deferasirox
Updated
12/06/2026
Medicine: Azacitidine Mylan azacitidine
Updated
12/06/2026
Medicine: Fubelv etanercept
Updated
12/06/2026
Document: Product Management Service (PMS) public API - Frequently asked questions (FAQs)
 New
12/06/2026
Medicine: Apremilast Accord apremilast
Updated
12/06/2026
Event: Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) new safety module
 New
12/06/2026
PSUSA: PSUSA/00000892/202511 - periodic safety update report single assessment cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide
New
12/06/2026
Medicine: Posaconazole Accord posaconazole
Updated
12/06/2026
Page: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings
 Updated
12/06/2026
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2026
 New
12/06/2026
Shortage: Salbutamol inhalation products salbutamol
Updated
12/06/2026
Event: Product Management Service (PMS) public API beta release - Technical overview and live demo
 New
12/06/2026
Medicine: LysaKare arginine; lysine
Updated
12/06/2026
Medicine: Anktiva nogapendekin alfa inbakicept
Updated
11/06/2026
PSUSA: PSUSA/00010217/202509 - periodic safety update report single assessment drospirenone / ethinylestradiol
New
11/06/2026
Medicine: Tenofovir disoproxil Zentiva tenofovir disoproxil
Updated
11/06/2026
Medicine: Teriflunomide Viatris (previously Teriflunomide Mylan) teriflunomide
Updated
11/06/2026
Post-authorisation: Pluvicto - withdrawal of application for variation to marketing authorisation lutetium (177Lu) vipivotide tetraxetan
Updated
11/06/2026
Medicine: Brineura cerliponase alfa
Updated
11/06/2026
Medicine: DuoPlavin clopidogrel; acetylsalicylic acid
Updated
11/06/2026
Medicine: Livtencity maribavir
Updated
11/06/2026
Medicine: Voxzogo vosoritide
Updated
11/06/2026
Medicine: Qtern saxagliptin; dapagliflozin
Updated
11/06/2026
Event: 20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP)
 Updated
11/06/2026
Event: Product Management Service (PMS) information day 2026
 Updated
11/06/2026
Medicine: Winrevair sotatercept
Updated
11/06/2026
Document: European Medicines Agency’s data protection notice for the EMA Account Management system
 Updated
11/06/2026
Page: Annual reports and work programmes
 Updated
11/06/2026
News: EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
 New
11/06/2026
Medicine: Edistride dapagliflozin
Updated
11/06/2026
Medicine: Forxiga dapagliflozin
Updated
11/06/2026
Event: Shortage prevention plan (SPP) workshop
 New
11/06/2026
Document: Change management activities delivery plan - HMA-EMA joint Big Data Steering Group
 Updated
10/06/2026
Event: Managing product data quality in PMS: processes, known issues, current status and best practices
 New
10/06/2026
PIP: EMA/PE/0000273488 - paediatric investigation plan rocatinlimab
Updated
10/06/2026
Medicine: Byannli (previously Paliperidone Janssen-Cilag International) paliperidone
Updated
10/06/2026
Medicine: Oczyesa octreotide
Updated
10/06/2026
Medicine: Vargatef nintedanib
Updated
10/06/2026
Medicine: Crysvita burosumab
Updated
10/06/2026
Medicine: Jemperli dostarlimab
Updated
10/06/2026
Medicine: Zejula niraparib
Updated
10/06/2026
Medicine: Slenyto melatonin
Updated
10/06/2026
Medicine: Upstaza eladocagene exuparvovec
Updated
10/06/2026
Event: Updates to industry contact management for authorisation products (IRIS)
 Updated
10/06/2026
Medicine: Bysumlog insulin lispro
Updated
10/06/2026
Document: List of eligible industry stakeholder organisations
 Updated
10/06/2026
Page: Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions
 Updated
10/06/2026
Document: EMA/HMA European platform for regulatory science research platform meeting – draft agenda
 Updated
10/06/2026
Page: Real-world evidence
 Updated
10/06/2026
Event: Cancer Medicines Forum: March 2026
 New
10/06/2026
Event: Quarterly System Demo - Q2 2026
 Updated
09/06/2026
Document: List of medicines currently in PRIME scheme
 Updated
09/06/2026
Medicine: Ultomiris ravulizumab
Updated
09/06/2026
Medicine: Rinvoq upadacitinib
Updated
09/06/2026
Medicine: Dovprela (previously Pretomanid FGK) pretomanid
Updated
09/06/2026
Medicine: Tepkinly epcoritamab
Updated
09/06/2026
Medicine: Sarclisa isatuximab
Updated
09/06/2026
Medicine: Scintimun besilesomab
Updated
09/06/2026
Medicine: Neofordex dexamethasone
Updated
09/06/2026
Medicine: Kineret anakinra
Updated
09/06/2026
Medicine: Orphacol cholic acid
Updated
09/06/2026
Document: Records of data processing activity regarding EMA Account Management System (public)
 New
09/06/2026
Event: Sixteenth industry stakeholder platform on research and development support
 New
09/06/2026
Medicine: Efmody hydrocortisone
Updated
09/06/2026
Document: 2025-2028 Work plan for the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP)
 New
09/06/2026
Medicine: Avtozma tocilizumab
Updated
09/06/2026
Document: Agenda - Clinical trials information system information day webinar
 Updated
09/06/2026
Document: Agenda - Challenges in drug development, regulation and clinical practice in immune thrombocytopenia
 Updated
09/06/2026
Document: Appendix 1: Acceptable intakes established for N-nitrosamines
 Updated
08/06/2026
Document: Agenda of the PRAC meeting 8-11 June 2026
 New
08/06/2026
PIP: EMEA-001563-PIP02-15-M01 - paediatric investigation plan ciprofloxacin hydrochloride
Updated
08/06/2026
Medicine: Omjjara momelotinib
Updated
08/06/2026
Medicine: Yescarta axicabtagene ciloleucel
Updated
08/06/2026
Medicine: Alecensa alectinib
Updated
08/06/2026
Medicine: Vyjuvek beremagene geperpavec
Updated
08/06/2026
Medicine: Xolair omalizumab
Updated
08/06/2026
Document: Applications for new human medicines under evaluation: June 2026
 New
08/06/2026
Page: Scientific publications
 Updated
08/06/2026
Page: Ebola
 Updated
08/06/2026
Document: Presentations - EnprEMA& ACT EU workshop on paediatric clinical trials
 New
08/06/2026
Medicine: Fintepla fenfluramine
Updated
08/06/2026
Document: Data protection notice for legal entity and bank account validation regarding payments
 Updated
08/06/2026
Medicine: Jentadueto linagliptin; metformin hydrochloride
Updated
08/06/2026
Document: Minutes of PRAC meeting on 7-10 April 2026
 New
05/06/2026
Document: Report - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
 New
05/06/2026
PSUSA: PSUSA/00000491/202506 - periodic safety update report single assessment calcifediol
New
05/06/2026
Medicine: Zarzio filgrastim
Updated
05/06/2026
Medicine: Ixchiq Chikungunya vaccine (live)
Updated
05/06/2026
Document: Member states contact points for translations review
 Updated
05/06/2026
Medicine: Ebymect dapagliflozin; metformin
Updated
05/06/2026
Medicine: Xigduo dapagliflozin; metformin
Updated
05/06/2026
Document: Standard operating procedure for the preparation of ESUAvet annual reports
 New
05/06/2026
Medicine: Dasselta desloratadine
Updated
05/06/2026
Medicine: HyQvia human normal immunoglobulin
Updated
05/06/2026
Document: Member states contact points for review of national versions of the content of mobile scanning and other technologies
 Updated
05/06/2026
Document: Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
 Updated
05/06/2026
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
05/06/2026
Document: Union Product Database (UPD) registration guide for UI and API users
 Updated
05/06/2026
Medicine: CellCept mycophenolate mofetil
Updated
05/06/2026
Medicine: Opsumit macitentan
Updated
05/06/2026
Medicine: Tivdak tisotumab vedotin
Updated
05/06/2026
Medicine: Idacio adalimumab
Updated
05/06/2026
Medicine: Insulin Aspart Injection insulin aspart
Updated
04/06/2026
Document: Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)
 Updated
04/06/2026
Document: Timetable: Safety referral (Article 107i, urgent Union procedure)
 Updated
04/06/2026
Document: Timetable: Non-safety referrals
 Updated
04/06/2026
Medicine: Tegsedi inotersen
Updated
04/06/2026
Medicine: Nugalviq govorestat
Updated
04/06/2026
Orphan: EU/3/13/1153 - orphan designation for treatment of plasma-cell myeloma daratumumab
Updated
04/06/2026
Medicine: Rapamune sirolimus
Updated
04/06/2026
Medicine: Rotarix rotavirus vaccine, live
Updated
04/06/2026
PIP: EMA/PE/0000232781 - paediatric investigation plan lenacapavir sodium / islatravir
New
04/06/2026
PIP: EMA/PE/0000232771 - paediatric investigation plan tacrolimus
New
04/06/2026
PIP: EMA/PE/0000232769 - paediatric investigation plan pegozafermin
New
04/06/2026
Medicine: Enflonsia clesrovimab
Updated
04/06/2026
PIP: EMA/PE/0000232764 - paediatric investigation plan zasocitinib
New
04/06/2026
PIP: EMA/PE/0000232763 - paediatric investigation plan icotrokinra
New
04/06/2026
PIP: EMA/PE/0000232638 - paediatric investigation plan Ifinatamab deruxtecan
New
04/06/2026
PIP: EMA/PE/0000232759 - paediatric investigation plan telitacicept
New
04/06/2026
PIP: EMA/PE/0000232171 - paediatric investigation plan Botulinum toxin type A
New
04/06/2026
Page: Artificial intelligence
 Updated
04/06/2026
Document: 2025 AI Observatory report
 New
04/06/2026
Document: Standard operating procedure for the contribution to the 3-yearly JIACRA reports
 New
04/06/2026
Page: Expert panel support for breakthrough medical devices: pilot programme
 Updated
04/06/2026
PIP: EMA/PE/0000230564 - paediatric investigation plan ezetimibe; rosuvastatin
New
04/06/2026
PIP: EMA/PE/0000230006 - paediatric investigation plan empagliflozin / sitagliptin
New
04/06/2026
PIP: EMA/PE/0000229841 - paediatric investigation plan itepekimab
New
04/06/2026
PIP: EMA/PE/0000227611 - paediatric investigation plan sacituzumab tirumotecan
New
04/06/2026
PIP: EMA/PE/0000183637 - paediatric investigation plan humanised afucosylated IgG1 monoclonal antibody against CCR8
New
04/06/2026
PIP: EMA/PE/0000232755 - paediatric investigation plan Dasiglucagon
New
03/06/2026
Document: PDCO minutes of the 21-24 April 2026 meeting
 New
03/06/2026
PIP: EMA/PE/0000232765 - paediatric investigation plan sargramostim
New
03/06/2026
PSUSA: PSUSA/00010508/202509 - periodic safety update report single assessment metronidazole / neomycin / nystatin
New
03/06/2026
Medicine: Kostaive zapomeran
Updated
03/06/2026
Medicine: Ameluz 5-aminolevulinic acid hydrochloride
Updated
03/06/2026
Medicine: Xeplion paliperidone
Updated
03/06/2026
Medicine: Namuscla Mexiletine
Updated
03/06/2026
Page: Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline
 Updated
03/06/2026
Shortage: Biltricide praziquantel
Updated
03/06/2026
Shortage: Insuman Basal and Comb 25 insulin human
Updated
03/06/2026
Shortage: Integrilin eptifibatide
Updated
03/06/2026
Shortage: Mimpara cinacalcet
Updated
03/06/2026
Document: Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making
 New
03/06/2026
Medicine: Lynparza olaparib
Updated
03/06/2026
Medicine: Sotyktu deucravacitinib
Updated
03/06/2026
News: EMA, AMA and African regulatory authorities join forces on Ebola outbreak response
 New
03/06/2026
Medicine: Sirturo bedaquiline
Updated
03/06/2026
Medicine: Vyndaqel tafamidis
Updated
03/06/2026
Medicine: Nexium Control esomeprazole
Updated
03/06/2026
Page: Medicines for human use under evaluation
 Updated
03/06/2026
Document: EMA’s API general terms and conditions of use - Terms of use
 Updated
03/06/2026
Document: Meeting summary - Medicine shortages SPOC working party meeting 15 April 2026
 New
02/06/2026
Medicine: Theralugand lutetium (177Lu) chloride
Updated
02/06/2026
Medicine: Orkambi lumacaftor; ivacaftor
Updated
02/06/2026
Document: Questions and answers on the refusal of a change to the marketing authorisation for Hetlioz (tasimelteon) (II-40)
 Updated
02/06/2026
Page: Website outages and upgrades
 Updated
02/06/2026
Medicine: Pazenir paclitaxel
Updated
02/06/2026
Medicine: Opdivo nivolumab
Updated
02/06/2026
Medicine: Zandoriah teriparatide
Updated
02/06/2026
Page: Languages on this website
 Updated
02/06/2026
Document: Policy 84: Multilingualism on the EMA website and in external communications
 Updated
02/06/2026
PIP: EMEA-001134-PIP01-11 - paediatric investigation plan chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2
Updated
02/06/2026
PSUSA: PSUSA/00001263/202507 - periodic safety update report single assessment escherichia coli lysate
New
02/06/2026
Medicine: Akynzeo netupitant; palonosetron
Updated
02/06/2026
Event: European platform for regulatory science research meeting: June 2026
New
02/06/2026
Document: Meeting summaries of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB)
 Updated
01/06/2026
Herbal: Lecithinum ex soya - herbal medicinal product Soya-bean lecithin
Updated
01/06/2026
Medicine: Emadine emedastine
Updated
01/06/2026
Medicine: Jinarc tolvaptan
Updated
01/06/2026
Medicine: Capvaxive pneumococcal polysaccharide conjugate vaccine (21-valent)
Updated
01/06/2026
Medicine: Zepzelca lurbinectedin
Updated
01/06/2026
Medicine: Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) lopinavir; ritonavir
Updated
01/06/2026
Medicine: Eurneffy epinephrine
Updated
01/06/2026
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC
 Updated
01/06/2026
Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)
Updated
01/06/2026
Medicine: Nemluvio nemolizumab
Updated
01/06/2026
Medicine: Carvykti ciltacabtagene autoleucel
Updated
01/06/2026
Medicine: Imatinib Accord imatinib
Updated
01/06/2026
Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 15 April 2026
 New
01/06/2026
Page: Combination Products Operational Group: agendas and highlight reports
 Updated
01/06/2026
Medicine: Kapruvia difelikefalin
Updated
01/06/2026
Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
 Updated
01/06/2026
News: United for Health: EMA in WorldPride 2026
New