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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 (169)

Date Content Status
11/11/2025
Document: Faecal microbiota transplantation EU-IN Horizon Scanning Report
 Updated
11/11/2025
Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)
Updated
11/11/2025
Medicine: Roctavian valoctocogene roxaparvovec
Updated
11/11/2025
Page: Medicine shortage communications (MSC)
 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: European Medicines Agency (EMA) and European Association of Urology (EAU) bilateral meeting
 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
Event: First European Medicines Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting
 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: Janumet sitagliptin; metformin
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
Event: Quarterly System Demo - Q4 2025
 New
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
10/11/2025
Event: Medicine shortages: EMA public webinar putting patients first
 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: Dupixent - withdrawal of application for variation to marketing authorisation dupilumab
Updated
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: Frontpro (previously Afoxolaner Merial) - opinion on variation to marketing authorisation afoxolaner
New
07/11/2025
Post-authorisation: Credelio - opinion on variation to marketing authorisation lotilaner
New
07/11/2025
Page: Personalised medicine in oncology
 New
07/11/2025
Page: Cancer medicines
 Updated
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
07/11/2025
Event: HMA/EMA multi-stakeholder workshop on artificial intelligence
 Updated
06/11/2025
Page: Website outages and upgrades
 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: Loargys pegzilarginase
Updated
05/11/2025
Medicine: Grasustek pegfilgrastim
Updated
05/11/2025
Event: Fifth Veterinary Big Data Stakeholder Forum
 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
Page: Substance and product data management services
 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
Medicine: Tevimbra tislelizumab
Updated
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
Event: EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer treatment optimisation
 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
Event: Fourth European Medicines Agency - Medtech Europe bilateral meeting
 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: Mekinist trametinib
Updated
03/11/2025
Medicine: Spexotras trametinib
Updated
03/11/2025
Document: Agenda of the CVMP meeting 4-6 November 2025
 New
03/11/2025
Medicine: Atectura Breezhaler indacaterol; mometasone
Updated
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
Medicine: Pyzchiva ustekinumab
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
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