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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 (92)

Date Content Status
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/0000235999 - paediatric investigation plan finerenone
Updated
03/07/2026
PIP: EMA/PE/0000237559 - paediatric investigation plan azilsartan medoxomil
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
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
 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; alpha-ketoglutaric acid; 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: Hetronifly serplulimab
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: Ztalmy ganaxolone
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