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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 (338)

Date Content Status
14/07/2026
Medicine: Poulvac Procerta HVT-ND Marek’s disease and Newcastle disease vaccine (live recombinant)
Updated
14/07/2026
PIP: EMA/PE/0000235924 - paediatric investigation plan Mitazalimab
New
14/07/2026
PIP: EMA/PE/0000240621 - paediatric investigation plan lunsekimig
New
14/07/2026
PIP: EMA/PE/0000241250 - paediatric investigation plan trilaciclib (dihydrochloride)
New
14/07/2026
PIP: EMA/PE/0000182809 - paediatric investigation plan afimkibart
New
14/07/2026
PIP: EMA/PE/0000232767 - paediatric investigation plan ve303-07: bacilli, strain from cluster xvii, (closest relative: clostridium_aq innocuum) liveve303-07; ve303-06: clostridia, strain from cluster xiva, (closest relative: dorea_a longicatena) live; ve303-05: clostridia, strain from cluster xiva, (closest relative: blautia sp001304935) live; ve303-03: clostridia, strain from cluster xiva, (closest relative: sellimonas intestinalis) live; ve303-02: clostridia, strain from cluster iv, (closest relative: anaerotruncus colihominis) liveve303-02; ve303-01: clostridia, strain from cluster xiva (closest relative: enterocloster bolteae) live; ve303-08: clostridia, strain from cluster iv, (closest relative: flavonifractor plautii), live; ve303-04: clostridia, strain from cluster xiva, (closest relative: clostridium_q symbiosum) live (ve303)
New
14/07/2026
PIP: EMEA-002828-PIP01-20 - paediatric investigation plan firsocostat; cilofexor
New
14/07/2026
PIP: EMEA-002004-PIP04-23 - paediatric investigation plan atacicept
New
14/07/2026
Document: Meeting report of the EMA cancer medicines forum 14 November 2025
 New
14/07/2026
PIP: EMA/PE/0000232778 - paediatric investigation plan duvakitug
New
14/07/2026
PIP: EMA/PE/0000232777 - paediatric investigation plan zosurabalpin
New
14/07/2026
PIP: EMA/PE/0000232760 - paediatric investigation plan riliprubart
New
14/07/2026
PIP: EMA/PE/0000236704 - paediatric investigation plan nucresiran
New
14/07/2026
PIP: EMA/PE/0000242278 - paediatric investigation plan betula pollen extract
Updated
14/07/2026
PIP: EMA/PE/0000226166 - paediatric investigation plan sparsentan
Updated
14/07/2026
PIP: EMA/PE/0000244768 - paediatric investigation plan darvadstrocel
Updated
14/07/2026
PIP: EMA/PE/0000242923 - paediatric investigation plan Lerodalcibep
Updated
14/07/2026
Medicine: Ekterly sebetralstat
Updated
14/07/2026
PSUSA: PSUSA/00000485/202511 - periodic safety update report single assessment caffeine / ergotamine
New
14/07/2026
PSUSA: PSUSA/00000313/202511 - periodic safety update report single assessment benazepril
New
14/07/2026
PSUSA: PSUSA/00003041/202512 - periodic safety update report single assessment carbaethopendecinium bromide / trimecaine hydrochloride
New
14/07/2026
Medicine: Qaialdo spironolactone
Updated
14/07/2026
Medicine: Tuznue trastuzumab
Updated
14/07/2026
Medicine: Hemgenix etranacogene dezaparvovec
Updated
14/07/2026
Medicine: Bildyos denosumab
Updated
14/07/2026
Event: Industry webinar on new electronic application form (eAF) version
 New
14/07/2026
Medicine: Bilprevda denosumab
Updated
14/07/2026
PSUSA: PSUSA/00010504/202512 - periodic safety update report single assessment ascorbic acid / rutoside, ascorbic acid / rutoside / alfatocopherol
New
14/07/2026
PSUSA: PSUSA/00000227/202511 - periodic safety update report single assessment apomorphine
New
14/07/2026
PSUSA: PSUSA/00003167/202512 - periodic safety update report single assessment dienogest
New
14/07/2026
Document: PRIME eligibility requests: 2027 deadlines for submission and timetable for assessment
 New
14/07/2026
PIP: EMA/PE/0000184114 - paediatric investigation plan duvakitug
New
14/07/2026
PIP: EMA/PE/0000242080 - paediatric investigation plan luveltamab tazevibulin
New
14/07/2026
Medicine: Dyrupeg pegfilgrastim
Updated
14/07/2026
PIP: EMA/PE/0000221389 - paediatric investigation plan darovasertib
New
14/07/2026
Medicine: Zefylti filgrastim
Updated
14/07/2026
Page: Changing the labelling and package leaflet (Article 61(3) notifications)
 Updated
14/07/2026
PIP: EMA/PE/0000232449 - paediatric investigation plan sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate
New
14/07/2026
PIP: EMA/PE/0000232782 - paediatric investigation plan (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-2-(2,6-dimethoxypyridin-4-yl)-4-(dimethylamino)-1-(2,3,6-trimethoxypyridin-4-yl)butan-2-ol tartrate
New
14/07/2026
PIP: EMA/PE/0000232780 - paediatric investigation plan probenecid
New
14/07/2026
PIP: EMA/PE/0000239504 - paediatric investigation plan zabilugene almadenorepvec
New
14/07/2026
Medicine: Vitrakvi larotrectinib
Updated
14/07/2026
PIP: EMA/PE/0000241614 - paediatric investigation plan calcium carbonate; cholecalciferol; risedronate sodium
New
14/07/2026
Document: Agenda of the CVMP meeting 14-16 July 2026
 New
14/07/2026
Document: Applications for new human medicines under evaluation: July 2026
 New
14/07/2026
Document: Medicinal products for human use: monthly figures - June 2026
 New
14/07/2026
Page: Clinical pharmacology and pharmacokinetics: questions and answers
 Updated
14/07/2026
Document: Agenda of the COMP Meeting 14-16 July 2026
 New
14/07/2026
PIP: EMA/PE/0000242940 - paediatric investigation plan buloxibutid sodium
New
14/07/2026
Medicine: Acvybra denosumab
Updated
14/07/2026
PIP: EMA/PE/0000245434 - paediatric investigation plan setmelanotide
Updated
14/07/2026
PIP: EMA/PE/0000233998 - paediatric investigation plan sebetralstat
Updated
14/07/2026
PIP: EMA/PE/0000241034 - paediatric investigation plan Lebrikizumab
Updated
14/07/2026
PIP: EMA/PE/0000240529 - paediatric investigation plan cagrilintide; semaglutide
Updated
14/07/2026
Page: Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalnce guidance - various strengths
 New
14/07/2026
Document: Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths
 New
14/07/2026
DHPC: Ixchiq - direct healthcare professional communication (DHPC) Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated
New
13/07/2026
Document: Decision of the Executive Director on rules governing the traineeship programme at the EMA
 Updated
13/07/2026
Event: SME info day - navigating EMA support: From development to market authorisation
 Updated
13/07/2026
Medicine: Hetronifly serplulimab
Updated
13/07/2026
PSUSA: PSUSA/00000810/202512 - periodic safety update report single assessment clomifene
New
13/07/2026
Document: Minutes of the COMP meeting 11-12 May 2026
 New
13/07/2026
PSUSA: PSUSA/00001731/202511 - periodic safety update report single assessment indapamide
New
13/07/2026
Page: Open letters
 Updated
13/07/2026
Document: Joint response from European Medicines Regulatory Network to letter from Health Action International and other health groups on missing clinical trial results in CTIS
 New
13/07/2026
Medicine: Libmyris adalimumab
Updated
13/07/2026
PSUSA: PSUSA/00002298/202512 - periodic safety update report single assessment caffeine / paracetamol / propyphenazone, paracetamol / propyphenazone
New
13/07/2026
PSUSA: PSUSA/00001720/202511 - periodic safety update report single assessment idarubicin
New
13/07/2026
PSUSA: PSUSA/00000409/202512 - periodic safety update report single assessment biclotymol / enoxolone / muramidase hydrochloride
New
13/07/2026
Medicine: Idacio adalimumab
Updated
13/07/2026
PSUSA: PSUSA/00003102/202511 - periodic safety update report single assessment vecuronium bromide
New
13/07/2026
PIP: EMEA-003356-PIP01-22 - paediatric investigation plan Inhibitor of receptor-interacting protein kinase 1 (ABBV-668)
Updated
13/07/2026
Medicine: Kostaive zapomeran
Updated
13/07/2026
Medicine: Humalog insulin lispro
Updated
13/07/2026
PSUSA: PSUSA/00002117/202511 - periodic safety update report single assessment naltrexone
New
13/07/2026
PSUSA: PSUSA/00002829/202511 - periodic safety update report single assessment sultamicillin
New
13/07/2026
Medicine: Abasaglar (previously Abasria) insulin glargine
Updated
13/07/2026
PSUSA: PSUSA/00003135/202512 - periodic safety update report single assessment yellow fever vaccine (live)
New
13/07/2026
Event: European platform for regulatory science research meeting: June 2026
Updated
13/07/2026
Document: Guidance for applicants for the preparation of the precise scope section of the variation application form
 Updated
13/07/2026
Document: Pre-notification check for type IB Variations
 Updated
13/07/2026
Document: Template - Application for transfer of marketing authorisation from transferor to transferee - cover letter (human)
 Updated
13/07/2026
Document: Pre-notification check for type IA/IAIN variations
 Updated
13/07/2026
Medicine: Lyumjev (previously Liumjev) insulin lispro
Updated
13/07/2026
Document: Agenda - EMA/HMA European platform for regulatory science research platform meeting
 Updated
13/07/2026
Page: Grouping of variations: questions and answers
 Updated
13/07/2026
Page: Pre-authorisation guidance
 Updated
13/07/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
 Updated
13/07/2026
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
 Updated
13/07/2026
Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1
 Updated
13/07/2026
Page: Transfer of marketing authorisation: questions and answers
 Updated
13/07/2026
Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers
 Updated
13/07/2026
Page: Extensions of marketing authorisations: questions and answers
 Updated
13/07/2026
Page: Post-authorisation safety studies (PASS)
 Updated
13/07/2026
Medicine: Paxlovid nirmatrelvir; ritonavir
Updated
13/07/2026
Page: Worksharing: questions and answers
 Updated
13/07/2026
Page: Type-II variations: questions and answers
 Updated
13/07/2026
Page: Type-IB variations: questions and answers
 Updated
13/07/2026
Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
 Updated
13/07/2026
Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
 Updated
10/07/2026
Medicine: Venclyxto venetoclax
Updated
10/07/2026
Medicine: Natpar parathyroid hormone
Updated
10/07/2026
Medicine: Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Updated
10/07/2026
Medicine: Esbriet pirfenidone
Updated
10/07/2026
Medicine: Neofordex dexamethasone
Updated
10/07/2026
Shortage: Azactam aztreonam
New
10/07/2026
Document: Scientific recommendations on classification of advanced therapy medicinal products
 Updated
10/07/2026
Document: User manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)
 Updated
10/07/2026
Document: Coding of indications in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
 Updated
10/07/2026
Document: HMA-EMA Network Data Steering Group: membership list
 Updated
10/07/2026
Medicine: Vaxchora cholera vaccine, oral, live
Updated
10/07/2026
Page: Antimicrobial resistance in veterinary medicine
 Updated
10/07/2026
Document: CVMP activities related to antimicrobials - Status report on EMA/CVMP activities (2021–2025) and EMANS 2028 Strategic Overview (Theme 4)
 New
10/07/2026
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 Updated
10/07/2026
Document: Cardiac valves - Notified Body 0344 - 20/12/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
 New
10/07/2026
Document: Female contraceptive - Notified Body 0123 - 08/05/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)
 New
10/07/2026
Medicine: Bomyntra denosumab
Updated
10/07/2026
Medicine: Olazax olanzapine
Updated
10/07/2026
Medicine: Nobivac NXT HCPCh feline calicivirosis, feline rhinotracheitis, feline panleucopenia and feline chlamydiosis (live) vaccine
Updated
10/07/2026
Medicine: Nobivac NXT HCP felid herpesvirus 1, strain G2620A, live; feline calicivirus, strain F9, live; feline panleucopenia virus, strain MW-1, live
Updated
10/07/2026
Medicine: Desloratadine Actavis desloratadine
Updated
10/07/2026
Medicine: Nobivac NXT HC feline calicivirosis and feline viral rhinotracheitis vaccine (live)
Updated
10/07/2026
Medicine: Desloratadine ratiopharm desloratadine
Updated
10/07/2026
Medicine: Fycompa perampanel
Updated
10/07/2026
Page: Enpr-EMA priority activities
 Updated
10/07/2026
Document: Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points
 Updated
10/07/2026
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026
 New
10/07/2026
Medicine: Ozempic semaglutide
Updated
10/07/2026
Medicine: Cometriq cabozantinib
Updated
10/07/2026
Medicine: Infanrix Hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)
Updated
10/07/2026
Medicine: Menveo meningococcal group A, C, W-135 and Y conjugate vaccine
Updated
10/07/2026
Document: PWCP 20th anniversary summary
 New
10/07/2026
PIP: EMEA-002601-PIP01-19 - paediatric investigation plan adeno-associated viral vector serotype 8 containing the human RPGR gene
Updated
10/07/2026
PIP: EMEA-002617-PIP01-19 - paediatric investigation plan ravagalimab
Updated
10/07/2026
PIP: EMEA-002430-PIP01-18 - paediatric investigation plan timrepigene emparvovec
Updated
10/07/2026
PIP: EMEA-001556-PIP01-13 - paediatric investigation plan Human recombinant interleukin-2
Updated
10/07/2026
PIP: EMEA-001693-PIP03-21 - paediatric investigation plan reparixin
Updated
10/07/2026
Document: Minutes - Enpr-EMA Coordinating Group meeting, April 2026
 New
10/07/2026
Document: Agenda - EnprEMA Coordinating Group meeting, April 2026
 New
10/07/2026
Event: Enpr-EMA Coordinating Group meeting April 2026
 New
10/07/2026
Document: Article 57 product data
 Updated
09/07/2026
Medicine: Zavesca miglustat
Updated
09/07/2026
Medicine: Ztalmy ganaxolone
Updated
09/07/2026
Medicine: Ryzneuta efbemalenograstim alfa
Updated
09/07/2026
Medicine: Adynovi rurioctocog alfa pegol
Updated
09/07/2026
Medicine: Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Updated
09/07/2026
Medicine: Evenity romosozumab
Updated
09/07/2026
Medicine: Mircera methoxy polyethylene glycol-epoetin beta
Updated
09/07/2026
Document: CTIS Simplification Task Force: topics analysed
 Updated
09/07/2026
Document: Agenda - Sixteenth industry stakeholder platform on research and development support
 Updated
09/07/2026
Medicine: Evkeeza evinacumab
Updated
09/07/2026
Medicine: Pyrukynd mitapivat
Updated
09/07/2026
Document: Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests
 Updated
09/07/2026
Event: Sixteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
 Updated
09/07/2026
Medicine: Locametz gozetotide
Updated
09/07/2026
Event: Sixteenth industry stakeholder platform on research and development support
 Updated
09/07/2026
Document: Presentation - SPOR and XEVMPD status update webinar - Q3 2026
 Updated
08/07/2026
Page: International arrangements
 Updated
08/07/2026
Page: New Zealand
 Updated
08/07/2026
Event: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course (Bucharest) - October 2026
 New
08/07/2026
Medicine: Ebixa memantine
Updated
08/07/2026
Medicine: Trazimera trastuzumab
Updated
08/07/2026
Document: Meeting Summary - PCWP/HCPWP joint meeting
 New
08/07/2026
Medicine: Wyost denosumab
Updated
08/07/2026
Medicine: Mepsevii vestronidase alfa
Updated
08/07/2026
Medicine: Altuvoct efanesoctocog alfa
Updated
08/07/2026
Medicine: Tolura telmisartan
Updated
08/07/2026
Medicine: Fruzaqla fruquintinib
Updated
08/07/2026
Document: EMA risk management information day
 New
08/07/2026
Document: Clinical Trial Information System (CTIS) - Sponsor handbook
 Updated
08/07/2026
Medicine: Ritonavir Viatris (previously Ritonavir Mylan) ritonavir
Updated
08/07/2026
Document: Working arrangement for the collaboration and exchange of information on therapeutic products and medicinal products between DG SANTE/EMA and the New Zealand Ministry of Health
 New
08/07/2026
Orphan: EU/3/26/3232 - orphan designation for treatment of Wilson's disease copper metabolism disorder
New
08/07/2026
Orphan: EU/3/26/3231 - orphan designation for treatment of narcolepsy alixorexton
New
08/07/2026
Orphan: EU/3/26/3243 - orphan designation for treatment of syndromic inherited retinal dystrophies of the rod-dominant phenotype allogeneic human induced pluripotent stem cell-derived photoreceptor precursor cells
New
08/07/2026
Orphan: EU/3/26/3233 - orphan designation for treatment of KCNT1-related epilepsy (S)-N-(2-(2-Cyclopropylpyridin-4-yl)-4,5,6,7-tetrahydrobenzo[d]oxazol-4-yl)-1-methyl-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide
New
08/07/2026
Orphan: EU/3/26/3235 - orphan designation for treatment of inherited retinal disease due to dysfunction in the USH2A gene antisense oligonucleotide against USH2A pre-mRNA
New
08/07/2026
Orphan: EU/3/26/3241 - orphan designation for treatment of pancreatic cancer quemliclustat
New
08/07/2026
Orphan: EU/3/26/3240 - orphan designation for treatment of peripheral T-cell lymphoma igermetostat maleate
New
08/07/2026
Orphan: EU/3/26/3239 - orphan designation for treatment of PIK3CA related overgrowth spectrum serabelisib
New
08/07/2026
PIP: EMA/PE/0000235869 - paediatric investigation plan humanised IgG1 monoclonal antibody against SEZ6, conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide
New
08/07/2026
PIP: EMA/PE/0000239491 - paediatric investigation plan IgG1 trispecific monoclonal antibody against T-cell receptor CD3, B-cell maturation antigen and G protein-coupled receptor class C group 5 member D
New
08/07/2026
PIP: EMA/PE/0000222352 - paediatric investigation plan clostridium botulinum a, strain pm-12759 hall-a, botulin a conjugated to protein ntnh, hemagglutinin ha17, hemagglutinin ha34, hemagglutinin ha23 and hemagglutinin ha48
New
08/07/2026
PIP: EMA/PE/0000240548 - paediatric investigation plan autologous t-cells transduced with a lentiviral vector expressing a chimeric antigen receptor against bcma and gprc5d
New
07/07/2026
Page: Download website data in JSON data format
 Updated
07/07/2026
Medicine: Fluenz influenza vaccine (live attenuated, nasal)
Updated
07/07/2026
Medicine: Sarclisa isatuximab
Updated
07/07/2026
Medicine: Ixchiq Chikungunya vaccine (live)
Updated
07/07/2026
Document: List of medicines currently in PRIME scheme
 Updated
07/07/2026
Medicine: Onpattro patisiran
Updated
07/07/2026
Medicine: Abevmy bevacizumab
Updated
07/07/2026
PIP: EMA/PE/0000241119 - paediatric investigation plan (12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11h-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide
New
07/07/2026
PIP: EMA/PE/0000239082 - paediatric investigation plan human (scfv)2-fab fusion protein against cd40l
New
07/07/2026
PIP: EMA/PE/0000241527 - paediatric investigation plan baxdrostat; dapagliflozin propanediol
New
07/07/2026
PIP: EMA/PE/0000241327 - paediatric investigation plan palopegteriparatide
Updated
07/07/2026
PIP: EMA/PE/0000238807 - paediatric investigation plan derivative of azabicycloheptane-carboxamide
Updated
07/07/2026
PIP: EMA/PE/0000232780 - paediatric investigation plan probenecid
New
07/07/2026
PIP: EMA/PE/0000231576 - paediatric investigation plan atrasentan
Updated
07/07/2026
PIP: EMA/PE/0000240469 - paediatric investigation plan levonorgestrel
Updated
07/07/2026
PIP: EMA/PE/0000240232 - paediatric investigation plan Brivaracetam
Updated
07/07/2026
PIP: EMA/PE/0000240971 - paediatric investigation plan rilpivirine hydrochloride; dolutegravir sodium
Updated
07/07/2026
Medicine: Telmisartan Actavis telmisartan
Updated
07/07/2026
Event: EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia
 Updated
07/07/2026
News: EMA fast tracks review of a medicine for metastatic pancreatic cancer
 New
07/07/2026
PIP: EMA/PE/0000237641 - paediatric investigation plan Difelikefalin
Updated
07/07/2026
PIP: EMA/PE/0000241538 - paediatric investigation plan finerenone
Updated
07/07/2026
Event: 20th anniversary of European Medicines Agency's Patients' and Consumers' Working Party (PCWP)
 Updated
07/07/2026
Event: PCWP/HCPWP joint meeting
 Updated
07/07/2026
Medicine: Xolremdi mavorixafor
Updated
07/07/2026
Event: SPOR and XEVMPD status update webinar - Q3 2026
 Updated
07/07/2026
Event: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance system
 New
07/07/2026
Page: Qualification of novel methodologies for medicine development
 Updated
07/07/2026
Document: Qualification of novel methodologies for medicinal product development: guidance to applicants
 Updated
06/07/2026
Medicine: Calquence acalabrutinib
Updated
06/07/2026
Medicine: Tysabri natalizumab
Updated
06/07/2026
Document: Agenda of the PRAC meeting 6-9 July 2026
 New
06/07/2026
Medicine: Enhertu trastuzumab deruxtecan
Updated
06/07/2026
Document: Agenda of the HMPC meeting 6-8 July 2026
 New
06/07/2026
Document: List of signals discussed at PRAC since September 2012
 Updated
06/07/2026
Page: Accessibility
 Updated
06/07/2026
Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (22 May 2026 - 25 June 2026)
 New
06/07/2026
Document: Start of procedure: Extension of marketing authorisation (22 May 2026 - 25 June 2026)
 New
06/07/2026
Medicine: Alprolix eftrenonacog alfa
Updated
06/07/2026
Event: 17th Industry Standing Group (ISG) meeting
 Updated
06/07/2026
Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 June 2026 PRAC
 New
06/07/2026
Document: PRAC recommendations on signals adopted at the 8-11 June 2026 PRAC meeting
 New
03/07/2026
Medicine: Rexatilux ranibizumab
Updated
03/07/2026
PIP: EMA/PE/0000234516 - paediatric investigation plan quemliclustat
New
03/07/2026
PIP: EMA/PE/0000230610 - paediatric investigation plan cetrelimab
New
03/07/2026
PIP: EMA/PE/0000238858 - paediatric investigation plan acetylsalicylic acid; rivaroxaban
New
03/07/2026
PIP: EMA/PE/0000182225 - paediatric investigation plan eneboparatide
New
03/07/2026
PIP: EMA/PE/0000237903 - paediatric investigation plan padeliporfin di-potassium
New
03/07/2026
PIP: EMA/PE/0000239753 - paediatric investigation plan maridebart cafraglutide
New
03/07/2026
Medicine: Redemplo plozasiran
Updated
03/07/2026
Medicine: Retsevmo selpercatinib
Updated
03/07/2026
Medicine: Pyzchiva ustekinumab
Updated
03/07/2026
Medicine: Opuviz aflibercept
Updated
03/07/2026
Medicine: Cejemly sugemalimab
Updated
03/07/2026
Medicine: Kesimpta ofatumumab
Updated
03/07/2026
Medicine: Lorviqua lorlatinib
Updated
03/07/2026
PIP: EMA/PE/0000229973 - paediatric investigation plan fosigotifator sodium tromethamine
Updated
03/07/2026
Medicine: Zegalogue dasiglucagon
Updated
03/07/2026
PIP: EMA/PE/0000227014 - paediatric investigation plan baxdrostat
New
03/07/2026
Document: Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities
 Updated
03/07/2026
PIP: EMA/PE/0000230592 - paediatric investigation plan gemcitabine hydrochloride
New
03/07/2026
PIP: EMA/PE/0000242035 - paediatric investigation plan puxitatug samrotecan
New
03/07/2026
PIP: EMA/PE/0000234339 - paediatric investigation plan SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda
Updated
03/07/2026
PIP: EMA/PE/0000237724 - paediatric investigation plan pimicotinib hydrochloride hydrate
Updated
03/07/2026
PIP: EMA/PE/0000237224 - paediatric investigation plan ocrelizumab
Updated
03/07/2026
PIP: EMA/PE/0000228372 - paediatric investigation plan borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine
Updated
03/07/2026
PIP: EMA/PE/0000237559 - paediatric investigation plan azilsartan medoxomil
Updated
03/07/2026
PIP: EMA/PE/0000235999 - paediatric investigation plan finerenone
Updated
03/07/2026
Event: Workshop on the use of external controls for evidence generation in regulatory decision-making
 Updated
03/07/2026
PIP: EMA/PE/0000235991 - paediatric investigation plan etimumotide; imsamotide
New
03/07/2026
PIP: EMA/PE/0000238063 - paediatric investigation plan taladegib
New
03/07/2026
PIP: EMA/PE/0000238632 - paediatric investigation plan avalglucosidase alfa
Updated
03/07/2026
Page: Variations requiring assessment (veterinary medicines)
 Updated
03/07/2026
Event: Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox
 New
03/07/2026
PIP: EMA/PE/0000226763 - paediatric investigation plan tofacitinib citrate
Updated
03/07/2026
Event: Meeting of the HMA-EMA group focused on AI with industry stakeholders - June 2026
 New
03/07/2026
PIP: EMA/PE/0000236669 - paediatric investigation plan ritlecitinib
Updated
03/07/2026
Medicine: Duvyzat givinostat
Updated
03/07/2026
PIP: EMA/PE/0000238977 - paediatric investigation plan eubacterial spores, purified from allogeneic faecal donations
Updated
03/07/2026
PIP: EMEA-003002-PIP04-23 - paediatric investigation plan avenciguat
New
03/07/2026
Page: Combination Products Operational Group: agendas and highlight reports
 Updated
03/07/2026
PIP: EMEA-002183-PIP03-23 - paediatric investigation plan imlifidase
New
03/07/2026
Medicine: NeoRecormon epoetin beta
Updated
03/07/2026
PIP: EMA/PE/0000229606 - paediatric investigation plan Deferoxamine (mesylate); histidine; tryptophan; aspartic acid; n-acetyl-histidine (monohydrate); glycine; arginine; potassium chloride; calcium chloride (dihydrate); sodium chloride; alanine; 3,4-dimethoxy-N-methylbenzohydroxamic; magnesium chloride hexahydrate; L-tryptophan; oxogluric acid; n-hydroxy-3
Updated
03/07/2026
PIP: EMA/PE/0000232894 - paediatric investigation plan adeno-associated viral vector serotype 9 containing the human MECP2 gene
New
03/07/2026
Medicine: Advagraf tacrolimus
Updated
03/07/2026
PIP: EMA/PE/0000232776 - paediatric investigation plan lunsekimig
New
03/07/2026
Event: Clinical Trials Information System (CTIS): Information day
 Updated
03/07/2026
PIP: EMA/PE/0000228536 - paediatric investigation plan enlicitide (decanoate)
Updated
03/07/2026
Shortage: Tegsedi inotersen
New
03/07/2026
Document: Medicine shortage communication (MSC): TEGSEDI® (inotersen sodium, 284 mg solution for injection in prefilled syringe): planned marketing cessation (discontinuation)
 New
03/07/2026
PIP: EMA/PE/0000238070 - paediatric investigation plan [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine
New
03/07/2026
PIP: EMA/PE/0000237220 - paediatric investigation plan rezafungin acetate
Updated
03/07/2026
PIP: EMA/PE/0000236239 - paediatric investigation plan empasiprubart
New
03/07/2026
PIP: EMA/PE/0000228512 - paediatric investigation plan satralizumab
Updated
02/07/2026
PIP: EMA/PE/0000232757 - paediatric investigation plan sonelokimab
New
02/07/2026
PIP: EMA/PE/0000182928 - paediatric investigation plan propranolol hydrochloride
New
02/07/2026
PIP: EMEA-003489-PIP01-23 - paediatric investigation plan sonrotoclax
New
02/07/2026
PIP: EMEA-003489-PIP02-23 - paediatric investigation plan sonrotoclax
New
02/07/2026
PIP: EMEA-003435-PIP02-23 - paediatric investigation plan allogeneic faecal microbiota, pooled (MaaT013)
New
02/07/2026
PIP: EMA/PE/0000232774 - paediatric investigation plan 7-fluoro-1-isopropyl-3-methyl-8-(6-(3-(piperidin-1-yl)propoxy)pyridin-3-yl)-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one (AZD1390)
New
02/07/2026
Medicine: Aquipta atogepant
Updated
02/07/2026
Medicine: Suliqua insulin glargine; lixisenatide
Updated
02/07/2026
Medicine: Xtandi enzalutamide
Updated
02/07/2026
News: EMA steps up efforts on medicines for women’s health
 New
02/07/2026
Medicine: Xofluza baloxavir marboxil
Updated
02/07/2026
Medicine: Trimbow beclometasone; formoterol; glycopyrronium bromide
Updated
02/07/2026
Medicine: Lunsumio mosunetuzumab
Updated
02/07/2026
Medicine: Alkindi hydrocortisone
Updated
02/07/2026
Document: Declaration of interests: Silvy da Rocha Dias
 Updated
02/07/2026
Document: Declaration of interests: Virginia Rojo Guerra
 Updated
02/07/2026
PIP: EMA/PE/0000233398 - paediatric investigation plan fenfluramine hydrochloride
Updated
02/07/2026
PIP: EMA/PE/0000229605 - paediatric investigation plan ravulizumab
Updated
02/07/2026
Document: Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - June 2026
 New
02/07/2026
Document: Organisation chart: Information Management
 Updated
02/07/2026
Medicine: Elaprase idursulfase
Updated
01/07/2026
PIP: EMA/PE/0000235658 - paediatric investigation plan asundexian
Updated
01/07/2026
PIP: EMA/PE/0000240018 - paediatric investigation plan tezepelumab
Updated
01/07/2026
PIP: EMA/PE/0000232302 - paediatric investigation plan filgotinib maleate
Updated
01/07/2026
PIP: EMA/PE/0000224087 - paediatric investigation plan vosoritide
Updated
01/07/2026
PIP: EMA/PE/0000233864 - paediatric investigation plan Daridorexant
Updated
01/07/2026
Medicine: Ontozry cenobamate
Updated
01/07/2026
Medicine: Ondibta insulin glargine
Updated
01/07/2026
Medicine: Gotenfia golimumab
Updated
01/07/2026
Medicine: Eydenzelt aflibercept
Updated
01/07/2026
Medicine: Zypadhera olanzapine
Updated
01/07/2026
Medicine: Braftovi encorafenib
Updated
01/07/2026
Medicine: Teriflunomide Viatris (previously Teriflunomide Mylan) teriflunomide
Updated
01/07/2026
Document: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
 Updated
01/07/2026
Document: Timetable: Type IB variation requiring linguistic review
 Updated
01/07/2026
Medicine: Koselugo selumetinib
Updated
01/07/2026
Medicine: Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) tenofovir disoproxil
Updated
01/07/2026
Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
 Updated
01/07/2026
Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
 Updated
01/07/2026
Medicine: Noxafil posaconazole
Updated
01/07/2026
Medicine: Wezenla ustekinumab
Updated
01/07/2026
Document: List of centrally authorised products with safety-related changes to the product information
 Updated
01/07/2026
PIP: EMA/PE/0000232765 - paediatric investigation plan sargramostim
New
01/07/2026
Document: Timetable: Post-authorisation safety study (PASS) protocols and final results
 Updated
01/07/2026
PIP: EMA/PE/0000232762 - paediatric investigation plan frexalimab
New
01/07/2026
PIP: EMA/PE/0000232758 - paediatric investigation plan remibrutinib
New
01/07/2026
PIP: EMA/PE/0000229486 - paediatric investigation plan histidine; tryptophan; aspartic acid; n-acetyl-histidine (monohydrate); glycine; alpha-ketoglutaric acid; arginine; potassium chloride; calcium chloride (dihydrate); sodium chloride; alanine; 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N); magnesium chloride hexahydrate
Updated
01/07/2026
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
 Updated
01/07/2026
PIP: EMA/PE/0000227151 - paediatric investigation plan vidofludimus calcium
New
01/07/2026
PIP: EMA/PE/0000239193 - paediatric investigation plan hafnium oxide
New
01/07/2026
PIP: EMA/PE/0000228269 - paediatric investigation plan garetosmab
Updated
01/07/2026
PIP: EMA/PE/0000235857 - paediatric investigation plan bupivacaine
Updated
01/07/2026
Medicine: Keytruda pembrolizumab
Updated
01/07/2026
PIP: EMA/PE/0000237870 - paediatric investigation plan senaparib
New
01/07/2026
PIP: EMA/PE/0000229480 - paediatric investigation plan ianalumab
Updated
01/07/2026
Medicine: Mulpleo (previously Lusutrombopag Shionogi) lusutrombopag
Updated
01/07/2026
Medicine: Erelzi etanercept
Updated
01/07/2026
Page: Plasma master file certificates
 Updated
01/07/2026
Medicine: Stocrin efavirenz
Updated