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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 (141)

Date Content Status
06/03/2026
PIP: EMA/PE/0000222532 - paediatric investigation plan tofacitinib
Updated
06/03/2026
PIP: EMA/PE/0000221604 - paediatric investigation plan ravulizumab
Updated
06/03/2026
PIP: EMA/PE/0000221583 - paediatric investigation plan famtozinameran; riltozinameran; tozinameran
Updated
06/03/2026
PIP: EMA/PE/0000225594 - paediatric investigation plan imlifidase
Updated
06/03/2026
PIP: EMA/PE/0000221462 - paediatric investigation plan [225Ac]Ac-PSMA-617
New
06/03/2026
PIP: EMA/PE/0000221213 - paediatric investigation plan blinatumomab
Updated
06/03/2026
PIP: EMA/PE/0000221296 - paediatric investigation plan ravulizumab
Updated
06/03/2026
PIP: EMA/PE/0000184081 - paediatric investigation plan etrasimod
Updated
06/03/2026
PIP: EMA/PE/0000183827 - paediatric investigation plan tabelecleucel
Updated
06/03/2026
PIP: EMA/PE/0000182607 - paediatric investigation plan Maribavir
Updated
06/03/2026
PIP: EMA/PE/0000182245 - paediatric investigation plan 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
New
06/03/2026
PIP: EMA/PE/0000182075 - paediatric investigation plan venetoclax
Updated
06/03/2026
PIP: EMA/PE/0000181243 - paediatric investigation plan glutamatergic neurotransmission enhancer BI 1569912
New
06/03/2026
PIP: EMA/PE/0000181174 - paediatric investigation plan Dasiglucagon
Updated
06/03/2026
PIP: EMA/PE/0000181050 - paediatric investigation plan lonigutamab
New
06/03/2026
Medicine: Sprycel dasatinib (anhydrous)
Updated
06/03/2026
Document: Minutes of the HMPC meeting 19-21 January 2026
 New
06/03/2026
Document: Opinion of the CVMP on the establishment of maximum residue limits: Fluralaner ( EMEA/V/MRL/004380/EXTN/0002)
 New
06/03/2026
Document: Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
 New
06/03/2026
Page: ICH E2D post-approval safety data management - scientific guideline
 Updated
06/03/2026
Document: EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
 New
06/03/2026
Document: Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - February 2026
 New
06/03/2026
Document: Darwin EU: Making health data count
 Updated
06/03/2026
PSUSA: PSUSA/00000594/202506 - periodic safety update report single assessment cefixime
New
06/03/2026
Medicine: MicardisPlus telmisartan; hydrochlorothiazide
Updated
06/03/2026
Medicine: Tyruko natalizumab
Updated
06/03/2026
Event: 16th Industry Standing Group (ISG) meeting
 Updated
06/03/2026
PSUSA: PSUSA/00002846/202504 - periodic safety update report single assessment tamoxifen
New
06/03/2026
Medicine: Opdivo nivolumab
Updated
06/03/2026
Page: Orphan designation: Overview
 Updated
05/03/2026
Medicine: Inhixa enoxaparin sodium
Updated
05/03/2026
Medicine: Waskyra etuvetidigene autotemcel
Updated
05/03/2026
PIP: EMA/PE/0000225681 - paediatric investigation plan recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1
Updated
05/03/2026
PIP: EMA/PE/0000225592 - paediatric investigation plan ulixacaltamide (hydrochloride)
New
05/03/2026
PIP: EMA/PE/0000225245 - paediatric investigation plan nedosiran
Updated
05/03/2026
PIP: EMA/PE/0000223498 - paediatric investigation plan Infigratinib
Updated
05/03/2026
PIP: EMA/PE/0000223490 - paediatric investigation plan Eptinezumab
Updated
05/03/2026
PIP: EMA/PE/0000223351 - paediatric investigation plan Cipaglucosidase alfa
Updated
05/03/2026
PIP: EMA/PE/0000223288 - paediatric investigation plan evenamide
Updated
05/03/2026
PIP: EMA/PE/0000222938 - paediatric investigation plan Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY); Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein; recombinant Neisseria meningitidis serogroup B protein 1; recombinant Neisseria meningitidis serogroup B protein 2; recombinant Neisseria meningitidis serogroup B protein 3; Neisseria meningitidis serogroup B Protein-based active substance (MenPenta vaccine)
Updated
05/03/2026
PIP: EMEA-003219-PIP01-22 - paediatric investigation plan inclacumab
Updated
05/03/2026
PSUSA: PSUSA/00001855/202505 - periodic safety update report single assessment levomethadone
New
05/03/2026
Post-authorisation: Scenesse - withdrawal of application for variation to marketing authorisation afamelanotide
Updated
05/03/2026
Medicine: Toujeo (previously Optisulin) insulin glargine
Updated
05/03/2026
Medicine: Apidra insulin glulisine
Updated
05/03/2026
Medicine: VacPertagen pertussis vaccine (recombinant, acellular, component, adsorbed)
Updated
05/03/2026
Medicine: Lantus insulin glargine
Updated
05/03/2026
Medicine: Insuman insulin human
Updated
05/03/2026
Medicine: Imatinib Teva imatinib
Updated
05/03/2026
Page: Variations not requiring assessment (veterinary medicines)
 Updated
05/03/2026
Page: Transferring a veterinary marketing authorisation
 Updated
05/03/2026
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)
 Updated
05/03/2026
Page: Clinical trials in human medicines
 Updated
05/03/2026
Page: Product-information requirements for veterinary medicines
 Updated
05/03/2026
News: New guidance on the conduct of clinical trials during public health emergencies in the EU
 New
05/03/2026
Medicine: Simponi golimumab
Updated
05/03/2026
Document: Agenda - Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026
 New
05/03/2026
Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026
 New
04/03/2026
Medicine: Eylea aflibercept
Updated
04/03/2026
Page: Plasma master file certificates
 Updated
04/03/2026
Medicine: mNexspike COVID-19 mRNA vaccine
Updated
04/03/2026
Medicine: Kefdensis denosumab
Updated
04/03/2026
Medicine: Otezla apremilast
Updated
04/03/2026
Medicine: Vitrakvi larotrectinib
Updated
04/03/2026
Medicine: Leqvio inclisiran
Updated
04/03/2026
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
04/03/2026
PIP: EMA/PE/0000230484 - paediatric investigation plan alprazolam
Updated
04/03/2026
PIP: EMA/PE/0000227908 - paediatric investigation plan nerandomilast
Updated
04/03/2026
PIP: EMA/PE/0000227558 - paediatric investigation plan danicopan
Updated
04/03/2026
PIP: EMA/PE/0000227526 - paediatric investigation plan ceftobiprole medocaril (sodium)
Updated
04/03/2026
PIP: EMA/PE/0000227462 - paediatric investigation plan deucrictibant monohydrate
Updated
04/03/2026
PIP: EMA/PE/0000227425 - paediatric investigation plan efgartigimod alfa
Updated
04/03/2026
Medicine: Hemgenix etranacogene dezaparvovec
Updated
04/03/2026
PIP: EMA/PE/0000227394 - paediatric investigation plan tezacaftor; ivacaftor
Updated
04/03/2026
PIP: EMA/PE/0000226957 - paediatric investigation plan efgartigimod alfa
Updated
04/03/2026
Document: Draft guidance on the conduct of clinical trials during public health emergencies
 New
04/03/2026
Document: Records of data processing activity for the handling the contribution towards commuting costs
 Updated
04/03/2026
Medicine: Xevudy sotrovimab
Updated
04/03/2026
Page: Data Analysis and Real World Interrogation Network (DARWIN EU)
 Updated
04/03/2026
Document: DARWIN EU Advisory Board: Membership
 Updated
04/03/2026
Document: DARWIN EU data partners onboarded in phases I, II, III and IV
 Updated
04/03/2026
Document: Darwin EU study: Co-prescribing medicines in pulmonary arterial hypertension
 New
04/03/2026
Document: Darwin EU study: How medicines are used to treat adults and children with lupus
 New
04/03/2026
Document: Darwin EU study: Clozapine and the incidence of severe neutropenia over time
 New
04/03/2026
Document: Darwin EU study: Treatment patterns and user characteristics for novel migraine medicines
 New
04/03/2026
Document: Darwin EU study: Overall survival in patients with non-small cell lung cancer treated with selected immunotherapies
 New
04/03/2026
Document: Darwin EU: Is there a risk of suicidality after taking the antibiotic doxycycline
 New
04/03/2026
Document: Darwin EU study: Is there a link between blood clots and common painkillers in women who use hormonal birth control
 New
04/03/2026
Document: Darwin EU: How often respiratory syncytial virus (RSV) affects different age groups in Europe
 New
04/03/2026
Document: Darwin EU study: Use of higher-risk antibiotics from the WHO Watch list, including azithromycin
 New
04/03/2026
Document: Darwin EU study: Background incidence rates of selected vaccine adverse events of special in Europe
 New
04/03/2026
Document: Minutes of the CAT meeting 21-23 January 2026
 New
03/03/2026
Document: Annual report on the use of the special contribution for orphan medicinal products - 2025
 New
03/03/2026
Document: Questions and answers on the use of out-of-specification batches of authorised cell and tissue-based advanced therapy medicinal products
 Updated
03/03/2026
Document: Consolidated 3-year work plan for the clinical domain
 New
03/03/2026
Document: Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 February 2026
 New
03/03/2026
Page: Medicines for human use under evaluation
 Updated
03/03/2026
PIP: EMA/PE/0000228283 - paediatric investigation plan balstilimab
New
03/03/2026
Medicine: Afqlir aflibercept
Updated
03/03/2026
Shortage: Ifosfamide ifosfamide
Updated
03/03/2026
Shortage: Cyclophosphamide cyclophosphamide
Updated
03/03/2026
Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
 Updated
03/03/2026
PIP: EMA/PE/0000226753 - paediatric investigation plan mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein; mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein; mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein
New
03/03/2026
Medicine: Entyvio vedolizumab
Updated
16/02/2023
News: Human medicines: highlights of 2022
 New
03/03/2026
Document: Human medicines highlights 2022
 Updated
03/03/2026
Medicine: Zeposia ozanimod
Updated
03/03/2026
Medicine: Vyloy zolbetuximab
Updated
03/03/2026
Medicine: Myqorzo aficamten
Updated
03/03/2026
Medicine: Aqneursa L-acetylleucine
Updated
03/03/2026
Page: Artificial intelligence
 Updated
03/03/2026
Document: Scientific Explorer - Frequently Asked Questions
 Updated
03/03/2026
Document: Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6
 Updated
02/03/2026
Page: Fees for veterinary medicines
 Updated
02/03/2026
Herbal: Combination: Hyperici herba - herbal medicinal product St. John's Wort
Updated
02/03/2026
Medicine: Lotilaner / Milbemycin Elanco lotilaner; milbemycin oxime
Updated
02/03/2026
Medicine: Nivestim filgrastim
Updated
02/03/2026
Medicine: Retacrit epoetin zeta
Updated
02/03/2026
Medicine: Lamzede velmanase alfa
Updated
02/03/2026
Medicine: Fingolimod Accord fingolimod
Updated
02/03/2026
Medicine: Rasilez aliskiren
Updated
02/03/2026
Event: 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan
 New
02/03/2026
Medicine: Pylclari piflufolastat (18F)
Updated
02/03/2026
Medicine: Herceptin trastuzumab
Updated
02/03/2026
Page: One Health approach
 Updated
02/03/2026
Event: Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service - February 2026
 Updated
02/03/2026
Event: European Medicines Agency (EMA) and European Alliance of Associations for Rheumatology (EULAR) bilateral meeting
 New
02/03/2026
Page: Medical devices
 Updated
02/03/2026
Document: Report - Highlights of the 15th Industry Standing Group (ISG) meeting
 Updated
02/03/2026
Page: Non-clinical development and evaluation of microbiome-based medicinal products - Scientific guideline
 New
02/03/2026
Document: Draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products
 New
02/03/2026
Medicine: Neoclarityn desloratadine
Updated
02/03/2026
Medicine: Nemluvio nemolizumab
Updated
02/03/2026
Medicine: Azomyr desloratadine
Updated
02/03/2026
Medicine: Aerius desloratadine
Updated
02/03/2026
Event: Electronic application form (eAF) Q&A clinic
 Updated
02/03/2026
Medicine: Nexium Control esomeprazole
Updated
02/03/2026
Medicine: Xbonzy denosumab
Updated
02/03/2026
Page: Quality of medicines: questions and answers - Part 1
 Updated
02/03/2026
Event: Healthcare Professionals' Working Party (HCPWP) plenary meeting February 2026
 Updated
02/03/2026
Event: Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
 Updated