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As of 1 October 2025, 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.

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Results (452)

Date	Content	Status
22/10/2026	Medicine: Vevzuo denosumab	Updated
22/10/2026	Medicine: Cejemly sugemalimab	Updated
22/10/2026	Medicine: Filgrastim Hexal filgrastim	Updated
22/10/2026	Medicine: Zarzio filgrastim	Updated
22/10/2026	Medicine: Amyvid florbetapir (18F)	Updated
22/10/2026	Medicine: Vydura rimegepant	Updated
22/10/2026	Medicine: Instanyl fentanyl	Updated
22/10/2026	Document: Start of procedure: Extension of marketing authorisation (18 September 2026 - 15 October 2026)	New
22/10/2026	Document: CHMP PROM minutes for the meeting on 13 April 2026	New
22/10/2026	Medicine: Kostaive zapomeran	Updated
22/10/2026	Medicine: Eklira Genuair aclidinium bromide	Updated
22/10/2026	Medicine: Duaklir Genuair aclidinium bromide; formoterol	Updated
22/10/2026	Medicine: Byfavo remimazolam	Updated
22/10/2026	Medicine: Taxotere docetaxel	Updated
22/10/2026	PIP: EMEA-003002-PIP04-23 - paediatric investigation plan avenciguat	Updated
22/10/2026	PIP: EMEA-002537-PIP02-19 - paediatric investigation plan darunavir; ritonavir	Updated
22/10/2026	Medicine: Kygevvi doxecitine; doxribtimine	Updated
22/10/2026	Event: Immunogenicity and efficacy of pneumococcal vaccines	New
21/10/2026	PSUSA: PSUSA/00000078/202601 - periodic safety update report single assessment alendronate	New
21/10/2026	Medicine: GONAL-f follitropin alfa	Updated
21/10/2026	Medicine: Vyvgart efgartigimod alfa	Updated
21/10/2026	Medicine: Rayvow lasmiditan	Updated
21/10/2026	Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2026	Updated
21/10/2026	Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 23 September 2026	New
21/10/2026	Document: Agenda - HMA / EMA multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations	Updated
21/10/2026	Document: CHMP PROM minutes for the meeting on 19 January 2026	New
21/10/2026	PIP: EMEA-002644-PIP01-19-M01 - paediatric investigation plan cyclophosphamide	Updated
21/10/2026	PIP: EMEA-001841-PIP01-15 - paediatric investigation plan bexagliflozin	Updated
21/10/2026	Medicine: Orladeyo berotralstat	Updated
21/10/2026	Medicine: Anzupgo delgocitinib	Updated
21/10/2026	Page: Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions	Updated
21/10/2026	Document: Vascular and cardiac prostheses – other - Notified Bodfy 0344 - 25/11/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)	New
21/10/2026	Document: General medicine therapeutic treatment instruments - Notified Body 2797 - 12/05/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)	New
21/10/2026	Medicine: Libmeldy autologous CD34+ cells encoding ARSA gene	Updated
21/10/2026	Medicine: Cavoley pegfilgrastim	Updated
21/10/2026	Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 10 September 2026	New
21/10/2026	Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 17 July 2026	New
21/10/2026	Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers	Updated
21/10/2026	Document: CHMP PROM minutes for the meeting on 16 February 2026	New
21/10/2026	Document: Template for HMPC Assessment Report Summary for the Public (ARSP)	New
21/10/2026	Document: List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)	Updated
20/10/2026	PSUSA: PSUSA/00010187/202601 - periodic safety update report single assessment amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application)	Updated
20/10/2026	Medicine: Imuldosa ustekinumab	Updated
20/10/2026	Medicine: Darunavir Viatris (previously Darunavir Mylan) darunavir	Updated
20/10/2026	Medicine: Deferasirox Accord deferasirox	Updated
20/10/2026	Medicine: Tosmova (previously Tocilizumab STADA and Tofidence) tocilizumab	Updated
20/10/2026	Medicine: Kanjinti trastuzumab	Updated
20/10/2026	Post-authorisation: Kaftrio - withdrawal of application for variation to marketing authorisation ivacaftor; tezacaftor; elexacaftor	Updated
20/10/2026	Medicine: Prevenar 20 (previously Apexxnar) pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)	Updated
20/10/2026	Document: Pilot phase for the revised pre-submission interactions: Annex to request for rapporteurship	Updated
20/10/2026	Medicine: Afqlir aflibercept	Updated
20/10/2026	Medicine: Nordimet methotrexate	Updated
20/10/2026	Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)	Updated
20/10/2026	Medicine: Enhertu trastuzumab deruxtecan	Updated
20/10/2026	Medicine: Degarelix Accord degarelix	Updated
20/10/2026	Medicine: Skyclarys omaveloxolone	Updated
20/10/2026	Medicine: Shingrix herpes zoster vaccine (recombinant, adjuvanted)	Updated
20/10/2026	Medicine: Victoza liraglutide	Updated
20/10/2026	Medicine: Exjade deferasirox	Updated
20/10/2026	Medicine: Jivi damoctocog alfa pegol	Updated
20/10/2026	Medicine: Polivy polatuzumab vedotin	Updated
20/10/2026	Medicine: Zolsketil pegylated liposomal doxorubicin	Updated
20/10/2026	Medicine: Xofigo radium Ra223 dichloride	Updated
20/10/2026	Medicine: Tookad padeliporfin	Updated
20/10/2026	Medicine: Jevtana cabazitaxel	Updated
20/10/2026	Medicine: Firmagon degarelix	Updated
20/10/2026	Medicine: Enzalutamide Viatris enzalutamide	Updated
20/10/2026	Medicine: Cabazitaxel Accord cabazitaxel	Updated
20/10/2026	Medicine: Poteligeo mogamulizumab	Updated
20/10/2026	Medicine: Beyonttra acoramidis	Updated
20/10/2026	Medicine: Columvi glofitamab	Updated
20/10/2026	Medicine: Ontozry cenobamate	Updated
20/10/2026	Medicine: Arikayce liposomal amikacin	Updated
20/10/2026	Medicine: Zinplava bezlotoxumab	Updated
20/10/2026	Page: Podcast: Inside EMA	Updated
20/10/2026	Page: Access to documents	Updated
20/10/2026	Page: How to prepare and review a summary of product characteristics	Updated
20/10/2026	Event: ACT EU workshop on multiplicity in confirmatory clinical trials: From two-arm to platform trials	Updated
20/10/2026	Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)	Updated
20/10/2026	Event: Second ACT EU webinar on contractual agreements	New
20/10/2026	Document: Records of data processing activity for the declaration of gainful employment of staff members’ spouses and registered partners	New
20/10/2026	Document: Recommended submission dates for veterinary medicinal products	Updated
20/10/2026	Document: Agenda - European Medicines Agency workshop on bacteriophage therapy	Updated
20/10/2026	Document: Records of data processing activity for the engagement in active senior initiative	New
20/10/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
20/10/2026	Event: Real-world data collection in Duchenne muscular dystrophy: Joint Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) multistakeholder workshop	Updated
20/10/2026	Medicine: Afinitor everolimus	Updated
20/10/2026	Medicine: Yondelis trabectedin	Updated
20/10/2026	Document: Agenda - Combination products operational group, In vitro diagnostics (IVD) stream, 21 October 2026	New
19/10/2026	Page: European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance reports	Updated
19/10/2026	Document: Terms of reference for the European Sales and Use of Antimicrobials for veterinary medicine (ESUAvet) network	New
19/10/2026	Medicine: Spectrila asparaginase	Updated
19/10/2026	Medicine: Capvaxive pneumococcal polysaccharide conjugate vaccine (21-valent)	Updated
19/10/2026	Medicine: mNexspike COVID-19 mRNA vaccine	Updated
19/10/2026	Medicine: Orphacol cholic acid	Updated
19/10/2026	Medicine: Delstrigo doravirine; lamivudine; tenofovir disoproxil	Updated
19/10/2026	Medicine: Pifeltro doravirine	Updated
19/10/2026	Medicine: Opuviz aflibercept	Updated
19/10/2026	Event: Clinical Trials Information System (CTIS) bitesize talk: CTIS training environment and role management	New
19/10/2026	Medicine: Siklos hydroxycarbamide	Updated
19/10/2026	Medicine: Pyrukynd mitapivat	Updated
19/10/2026	Medicine: Eltrombopag Accord eltrombopag	Updated
19/10/2026	Medicine: Febuxostat Viatris (previously Febuxostat Mylan) febuxostat	Updated
19/10/2026	Medicine: Fasenra benralizumab	Updated
19/10/2026	Medicine: Diacomit stiripentol	Updated
19/10/2026	Document: Agenda - EMA Methodology Working Party (MWP) interested parties meeting 2026	New
19/10/2026	Medicine: Beromun tasonermin	Updated
19/10/2026	Medicine: Vizimpro dacomitinib	Updated
19/10/2026	Medicine: Iressa gefitinib	Updated
19/10/2026	Event: EMA Methodology Working Party interested parties meeting 2026	Updated
19/10/2026	Page: Data quality framework for medicines regulation	Updated
19/10/2026	Document: Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports	New
19/10/2026	Medicine: Yesafili aflibercept	Updated
19/10/2026	Medicine: Vgenfli aflibercept	Updated
19/10/2026	Medicine: Pavblu aflibercept	Updated
19/10/2026	Medicine: Mynzepli aflibercept	Updated
19/10/2026	Medicine: Eyluxvi aflibercept	Updated
19/10/2026	Medicine: Eylea aflibercept	Updated
19/10/2026	Medicine: Eiyzey aflibercept	Updated
19/10/2026	Medicine: Afiveg aflibercept	Updated
19/10/2026	Medicine: Baiama aflibercept	Updated
19/10/2026	Medicine: Eydenzelt aflibercept	Updated
19/10/2026	Document: Agenda - 21st industry stakeholder platform - operation of EU pharmacovigilance	Updated
19/10/2026	Medicine: Ahzantive aflibercept	Updated
19/10/2026	Scientific guideline: Platform trials - Scientific guideline	Updated
19/10/2026	Document: Reflection paper on methodological aspects in confirmatory platform trials	New
19/10/2026	Scientific guideline: Clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline	Updated
19/10/2026	Document: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)	New
19/10/2026	Document: Day 80 assessment report - Clinical template with guidance - Rev. 10.26 - Revamp	Updated
19/10/2026	Document: Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics	New
16/10/2026	Medicine: Padcev enfortumab vedotin	Updated
16/10/2026	Medicine: Cibinqo abrocitinib	Updated
16/10/2026	Medicine: Idefirix imlifidase	Updated
16/10/2026	Medicine: Plegridy peginterferon beta-1a	Updated
16/10/2026	Medicine: HyQvia human normal immunoglobulin	Updated
16/10/2026	Medicine: Ocrevus ocrelizumab	Updated
16/10/2026	Document: Agenda - Medicine Shortages SPOC Working Party meeting 13-14 October 2026	Updated
16/10/2026	Medicine: Saphnelo anifrolumab	Updated
16/10/2026	Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP	Updated
16/10/2026	Medicine: Afstyla lonoctocog alfa	Updated
16/10/2026	Document: CHMP PROM minutes for the meeting on 1 December 2025	New
16/10/2026	Medicine: Stelara ustekinumab	Updated
16/10/2026	Medicine: Idelvion albutrepenonacog alfa	Updated
16/10/2026	Medicine: Remicade infliximab	Updated
16/10/2026	Medicine: Deferasirox Mylan deferasirox	Updated
16/10/2026	Medicine: Foundayo Orforglipron	New
16/10/2026	Medicine: Fovlussea ranibizumab	New
16/10/2026	Medicine: Yuviwel Navepegritide	New
16/10/2026	Medicine: Neuzafy filgrastim	New
16/10/2026	Medicine: Kizfizo temozolomide	New
16/10/2026	Medicine: Mylotarg gemtuzumab ozogamicin	Updated
16/10/2026	News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026	New
16/10/2026	News: New oral GLP-1 medicine for weight management and type 2 diabetes	New
16/10/2026	Post-authorisation: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) - opinion on variation to marketing authorisation pandemic influenza vaccine (H5N1) (live attenuated, nasal)	New
16/10/2026	Post-authorisation: Talvey - opinion on variation to marketing authorisation talquetamab	New
16/10/2026	Post-authorisation: Ibrance - withdrawal of application for variation to marketing authorisation palbociclib	New
16/10/2026	Post-authorisation: Kyinsu - opinion on variation to marketing authorisation insulin icodec; semaglutide	New
16/10/2026	Post-authorisation: Tukysa - opinion on variation to marketing authorisation tucatinib	New
16/10/2026	Document: Overview of (invented) names reviewed in September 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 15 October 2026	New
16/10/2026	Page: Cancer Medicines Pathfinder	Updated
16/10/2026	Medicine: Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence	Updated
16/10/2026	Page: Combination Products Operational Group: agendas and highlight reports	Updated
16/10/2026	Document: Annex to 23-26 March 2026 CHMP minutes	New
16/10/2026	Document: Minutes of the CHMP meeting 23-26 March 2026	New
16/10/2026	Scientific guideline: Clinical investigation of immunosuppressants for solid organ transplantation - Scientific guideline	Updated
16/10/2026	Document: Concept paper on clinical trials in recipients of kidney transplantation	New
15/10/2026	Event: Seventeenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines	Updated
15/10/2026	Medicine: Optruma raloxifene	Updated
15/10/2026	PSUSA: PSUSA/00001694/202603 - periodic safety update report single assessment hydroxyethyl starch, hydroxyethyl starch combinations	New
15/10/2026	Referral: Rifadin oral suspension and syrup and associated names - referral rifampicin	Updated
15/10/2026	Medicine: Ratiograstim filgrastim	Updated
15/10/2026	Medicine: Tevagrastim filgrastim	Updated
15/10/2026	Medicine: Elaprase idursulfase	Updated
15/10/2026	Medicine: Mirvaso brimonidine	Updated
15/10/2026	Medicine: Rasonque Daraxonrasib	New
15/10/2026	News: EMA recommends authorisation of Rasonque for metastatic pancreatic cancer	New
15/10/2026	Event: EMA paediatric investigation plans in-person training course	New
15/10/2026	Medicine: Cabometyx cabozantinib	Updated
15/10/2026	Medicine: Nexviadyme avalglucosidase alfa	Updated
15/10/2026	Document: Draft reflection paper on the investigation of drug interactions of herbal medicinal products	New
15/10/2026	Medicine: Koselugo selumetinib	Updated
15/10/2026	Page: Academia	Updated
14/10/2026	PIP: EMEA-002727-PIP03-23 - paediatric investigation plan nivolumab; relatlimab	Updated
14/10/2026	Medicine: Dovprela (previously Pretomanid FGK) pretomanid	Updated
14/10/2026	Medicine: Fymskina ustekinumab	Updated
14/10/2026	Medicine: Vyndaqel tafamidis	Updated
14/10/2026	Medicine: Welireg belzutifan	Updated
14/10/2026	Medicine: Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) tenofovir disoproxil	Updated
14/10/2026	Medicine: Poherdy pertuzumab	Updated
14/10/2026	Document: Outcome of written procedures finalised during the period from 04 June 2026 to 22 September 2026	New
14/10/2026	Medicine: Iasibon ibandronic acid	Updated
14/10/2026	PIP: EMA/PE/0000243861 - paediatric investigation plan venglustat	Updated
14/10/2026	PIP: EMA/PE/0000258095 - paediatric investigation plan levodopa; carbidopa monohydrate	New
14/10/2026	PIP: EMA/PE/0000244980 - paediatric investigation plan mirabegron; solifenacin	New
14/10/2026	PIP: EMA/PE/0000240600 - paediatric investigation plan mirabegron; solifenacin	New
14/10/2026	PIP: EMA/PE/0000243891 - paediatric investigation plan azacitidine; cedazuridine	New
14/10/2026	Medicine: Humira adalimumab	Updated
14/10/2026	PIP: EMA/PE/0000245064 - paediatric investigation plan avutometinib; defactinib	New
14/10/2026	Page: Women's health	Updated
14/10/2026	Medicine: Pritor telmisartan	Updated
14/10/2026	Event: Regulatory perspectives on herbal medicinal / botanical drug product development: Joint FDA / EMA workshop	Updated
14/10/2026	Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine	Updated
14/10/2026	Medicine: Nemluvio nemolizumab	Updated
14/10/2026	Medicine: mResvia respiratory syncytial virus mRNA vaccine	Updated
14/10/2026	Event: Meeting of the HMA-EMA group focused on AI with industry stakeholders - October 2026	New
14/10/2026	PIP: EMA/PE/0000245149 - paediatric investigation plan mifepristone; misoprostol	New
14/10/2026	PIP: EMA/PE/0000241632 - paediatric investigation plan linaprazan glurate	New
14/10/2026	PIP: EMA/PE/0000245628 - paediatric investigation plan ivonescimab	New
14/10/2026	PIP: EMA/PE/0000245862 - paediatric investigation plan ivonescimab	New
14/10/2026	PIP: EMA/PE/0000235505 - paediatric investigation plan tislelizumab	New
14/10/2026	PIP: EMA/PE/0000234649 - paediatric investigation plan pasritamig	New
14/10/2026	PIP: EMEA-003313-PIP02-23 - paediatric investigation plan povorcitinib	New
14/10/2026	PIP: EMA/PE/0000223258 - paediatric investigation plan afimkibart	New
14/10/2026	PIP: EMA/PE/0000223040 - paediatric investigation plan iloperidone	New
14/10/2026	PIP: EMA/PE/0000183462 - paediatric investigation plan autologous regulatory T lymphocytes CD3+ CD4+ CD25+ CD127- FoxP3+, ex-vivo expanded (PolTreg-T1D)	New
14/10/2026	Scientific guideline: Investigation of bioequivalence - Scientific guideline	Updated
14/10/2026	Medicine: Denosumab Ascend denosumab	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development: CHMP qualification opinions	New
13/10/2026	Page: Qualification of novel methodologies for medicine development: Letters of support	New
13/10/2026	Medicine: Revatio sildenafil	Updated
13/10/2026	Medicine: Lyrica pregabalin	Updated
13/10/2026	Medicine: Viagra sildenafil	Updated
13/10/2026	Medicine: Olumiant baricitinib	Updated
13/10/2026	Medicine: Jemperli dostarlimab	Updated
13/10/2026	Medicine: Fingolimod Accord fingolimod	Updated
13/10/2026	Medicine: Cometriq cabozantinib	Updated
13/10/2026	Medicine: Imfinzi durvalumab	Updated
13/10/2026	Medicine: Rinvoq upadacitinib	Updated
13/10/2026	EU-M4all: Mosquirix - opinion on medicine for use outside EU Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)	Updated
13/10/2026	Medicine: Bemfola follitropin alfa	Updated
13/10/2026	Document: Agenda - PDCO agenda of the 13-16 October 2026 meeting	New
13/10/2026	Medicine: Nexium Control esomeprazole	Updated
13/10/2026	Document: Business process description for medical devices	Updated
13/10/2026	Medicine: Intuniv guanfacine	Updated
13/10/2026	Document: Voluntary data submission (VDS) pilot application form	Updated
13/10/2026	Medicine: Qalsody tofersen	Updated
13/10/2026	Document: Article 57 product data	Updated
13/10/2026	Event: IncreaseNET and EU-Innovation Network 2026 Innovation & Competitiveness Summit: Strengthening Europe's Ecosystem	New
13/10/2026	Document: HMPC: overview of assessment work - priority list	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development (QoNM)	Updated
13/10/2026	Page: Qualification of novel methodologies for medicine development: High-level information on CHMP qualification advice	New
13/10/2026	Event: Risk management information day 2022	Updated
13/10/2026	Document: Appendix 1: Acceptable intakes established for N-nitrosamines	Updated
12/10/2026	Medicine: Casgevy exagamglogene autotemcel	Updated
12/10/2026	Medicine: Rhokiinsa netarsudil	Updated
12/10/2026	Medicine: Roclanda latanoprost / netarsudil	Updated
12/10/2026	Medicine: Duvyzat givinostat	Updated
12/10/2026	Medicine: Lazcluze lazertinib	Updated
12/10/2026	Medicine: Altuvoct efanesoctocog alfa	Updated
12/10/2026	Medicine: Ofev nintedanib	Updated
12/10/2026	Page: New Approach Methodologies Operational Expert Group	New
12/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2026	Updated
12/10/2026	Document: Annex to agenda of the CHMP meeting 12-15 October 2026	New
12/10/2026	Document: Agenda of the CHMP meeting 12-15 October 2026	New
12/10/2026	Medicine: Sunitinib Accord sunitinib	Updated
12/10/2026	Medicine: Daybu trofinetide	Updated
12/10/2026	Scientific guideline: Concept paper on the need for the guideline on the clinical investigation of medicinal products for the treatment of inherited retinal dystrophies - Scientific guideline	New
09/10/2026	Medicine: Etcamah camizestrant	Updated
09/10/2026	PIP: EMA/PE/0000183092 - paediatric investigation plan polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain (NNC0487-0111)	New
09/10/2026	PIP: EMA/PE/0000180736 - paediatric investigation plan brogidirsen	New
09/10/2026	Document: Medicinal products for human use: monthly figures - September 2026	New
09/10/2026	Document: Annual report of the Pharmacovigilance Inspectors Working Group for 2025	New
09/10/2026	Medicine: Pylclari piflufolastat (18F)	Updated
09/10/2026	Page: Paediatric investigation plans	Updated
09/10/2026	Page: Paediatric investigation plans: questions and answers	Updated
09/10/2026	Post-authorisation: Kalydeco - withdrawal of application for variation to marketing authorisation ivacaftor	Updated
09/10/2026	Document: Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards	Updated
09/10/2026	Document: European Medicines Agency policy on changes in scope of paediatric investigation plan (PIP) decisions	Updated
09/10/2026	DHPC: Ocrevus - direct healthcare professional communication (DHPC) ocrelizumab	New
09/10/2026	Medicine: Stemyca equine umbilical cord mesenchymal stem cells	New
09/10/2026	Medicine: Bovilis Lumpyvax Lumpy skin disease vaccine (live)	New
09/10/2026	News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 October 2026	New
09/10/2026	News: EMA recommends authorisation of veterinary vaccine for lumpy skin disease in cattle	New
09/10/2026	Medicine: Giapreza angiotensin II	Updated
09/10/2026	Event: 21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance	New
09/10/2026	Document: Decision of the Management Board amending budget No. 01, amending appropriations in budget 2026 and transfer of appropriations	New
09/10/2026	Document: Applications for new human medicines under evaluation: October 2026	New
09/10/2026	Medicine: Svariya (previously Rivaroxaban Koanaa) rivaroxaban	Updated
09/10/2026	PIP: EMA/PE/0000245485 - paediatric investigation plan ustekinumab	Updated
09/10/2026	PIP: EMA/PE/0000247846 - paediatric investigation plan arimoclomol citrate	Updated
09/10/2026	PIP: EMA/PE/0000245644 - paediatric investigation plan navenibart	Updated
09/10/2026	PIP: EMA/PE/0000245980 - paediatric investigation plan sepofarsen	Updated
09/10/2026	PIP: EMA/PE/0000245997 - paediatric investigation plan ketamine; sufentanil	Updated
09/10/2026	PIP: EMA/PE/0000245698 - paediatric investigation plan tolebrutinib	Updated
09/10/2026	PIP: EMA/PE/0000245423 - paediatric investigation plan human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein	Updated
09/10/2026	PIP: EMA/PE/0000245173 - paediatric investigation plan iptacopan	Updated
09/10/2026	PIP: EMA/PE/0000246985 - paediatric investigation plan cedazuridine; decitabine	Updated
09/10/2026	PIP: EMA/PE/0000245146 - paediatric investigation plan Insulin lispro (BC222)	Updated
09/10/2026	PIP: EMA/PE/0000244420 - paediatric investigation plan vamorolone	Updated
09/10/2026	PIP: EMA/PE/0000242381 - paediatric investigation plan mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)	Updated
09/10/2026	PIP: EMA/PE/0000227737 - paediatric investigation plan Galcanezumab	Updated
09/10/2026	PIP: EMA/PE/0000238109 - paediatric investigation plan bempedoic acid (ETC-1002)	Updated
09/10/2026	PIP: EMA/PE/0000241641 - paediatric investigation plan Live, attenuated, dengue virus, serotype 1 (DENV1); live, attenuated, chimeric dengue virus, serotype 2 (DENV2); Live, attenuated, dengue virus, serotype 3 (DENV3); Live, attenuated, dengue virus, serotype 4 (DENV4)	Updated
09/10/2026	PIP: EMA/PE/0000242151 - paediatric investigation plan erenumab	Updated
09/10/2026	PIP: EMA/PE/0000243984 - paediatric investigation plan disitamab vedotin	Updated
09/10/2026	PIP: EMA/PE/0000242247 - paediatric investigation plan fitusiran	Updated
09/10/2026	PIP: EMA/PE/0000244179 - paediatric investigation plan Indacaterol (acetate); mometasone (furoate); glycopyrronium bromide	Updated
09/10/2026	Document: Timetable: Extension application - ATMP	Updated
09/10/2026	Document: Timetable: Extension application	Updated
08/10/2026	Scientific guideline: Download website data in JSON data format - Scientific guideline	Updated
08/10/2026	Medicine: Hetronifly serplulimab	Updated
08/10/2026	News: Clinical trial applications advice pilot becomes permanent	New
08/10/2026	Scientific guideline: Demonstration of therapeutic equivalence for nasal products - Scientific guideline	Updated
08/10/2026	Document: Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products	New
08/10/2026	PIP: EMA/PE/0000261512 - paediatric investigation plan Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes	Updated
08/10/2026	Event: Clinical Trials Information System (CTIS): Walk-in clinic October 2026	Updated
08/10/2026	Medicine: Mvasi bevacizumab	Updated
08/10/2026	Document: Agenda - Combination products operational group, MD stream, 8 October 2026	New
08/10/2026	Medicine: Mounjaro tirzepatide	Updated
08/10/2026	Document: Final programming document 2026-28	Updated
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 15-18 September 2025	Updated
08/10/2026	Document: Annex to 15-18 September 2025 CHMP Minutes	New
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2026	Updated
08/10/2026	Document: Annex to 20-23 July 2026 CHMP Minutes	New
08/10/2026	Document: Minutes of the CHMP meeting 20-23 July 2026	New
08/10/2026	Event: Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2026	Updated
08/10/2026	Document: Annex to 20-23 April 2026 CHMP Minutes	New
08/10/2026	Document: Minutes of the CHMP meeting 20-23 April 2026	New
08/10/2026	Medicine: Tepmetko tepotinib	Updated
08/10/2026	PSUSA: PSUSA/00010947/202602 - periodic safety update report single assessment telmisartan / indapamide	New
08/10/2026	PSUSA: PSUSA/00010280/202602 - periodic safety update report single assessment acetylsalicylic acid / atorvastatin / ramipril	New
08/10/2026	Medicine: Lucentis ranibizumab	Updated
08/10/2026	Medicine: Increlex mecasermin	Updated
08/10/2026	Medicine: Tafamidis Accord tafamidis	Updated
08/10/2026	PSUSA: PSUSA/00001568/202602 - periodic safety update report single assessment granisetron (all formulations except transdermal patch)	New
07/10/2026	PSUSA: PSUSA/00009266/202601 - periodic safety update report single assessment potassium canrenoate	New
07/10/2026	Medicine: Zinmyleo trilaciclib	Updated
07/10/2026	Medicine: Kuvan sapropterin	Updated
07/10/2026	Medicine: Nulibry fosdenopterin	Updated
07/10/2026	Document: Minutes of the HMPC meeting 6-8 July 2026	Updated
07/10/2026	Medicine: Imbruvica ibrutinib	Updated
07/10/2026	Medicine: Mysimba naltrexone; bupropion	Updated
07/10/2026	Medicine: Zokinvy lonafarnib	Updated
07/10/2026	Medicine: Ritonavir Viatris (previously Ritonavir Mylan) ritonavir	Updated
07/10/2026	Medicine: Lunsumio mosunetuzumab	Updated
07/10/2026	Medicine: Calquence acalabrutinib	Updated
07/10/2026	Orphan: EU/3/18/2068 - orphan designation for treatment of growth hormone deficiency somapacitan	Updated
07/10/2026	Medicine: Sogroya somapacitan	Updated
07/10/2026	Medicine: Besremi ropeginterferon alfa-2b	Updated
07/10/2026	Medicine: Brukinsa zanubrutinib	Updated
07/10/2026	Medicine: Thiotepa Riemser thiotepa	Updated
07/10/2026	Medicine: Scenesse afamelanotide	Updated
07/10/2026	PSUSA: PSUSA/00001204/202602 - periodic safety update report single assessment eletriptan	New
07/10/2026	PSUSA: PSUSA/00009057/202601 - periodic safety update report single assessment argatroban	New
07/10/2026	Medicine: Cenrifki tolebrutinib	Updated
06/10/2026	Page: PRIME: eligibility requests and outcomes	New
06/10/2026	Page: PRIME: priority medicines	Updated
06/10/2026	Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meetings of 2026	New
06/10/2026	Document: List of medicines currently in PRIME scheme	Updated
06/10/2026	Medicine: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) telmisartan	Updated
06/10/2026	Page: How to submit information on authorised and investigational medicines	Updated
06/10/2026	Page: Reporting requirements for marketing-authorisation holders	Updated
06/10/2026	Medicine: Otulfi ustekinumab	Updated
06/10/2026	Document: PRAC rules of procedure	Updated
06/10/2026	Medicine: Steqeyma ustekinumab	Updated
06/10/2026	Scientific guideline: Good pharmacogenomic practice - Scientific guideline	Updated
06/10/2026	Document: Concept paper on the guideline revision on good pharmacogenomic practice	New
06/10/2026	Event: Management Board meeting: 30 September 2026	Updated
06/10/2026	Document: Agenda - Management Board meeting: 30 September 2026	Updated
06/10/2026	PSUSA: PSUSA/00001584/202602 - periodic safety update report single assessment haemophilus type b conjugate vaccines	New
06/10/2026	PSUSA: PSUSA/00001955/202602 - periodic safety update report single assessment mefloquine	New
06/10/2026	PSUSA: PSUSA/00001248/202602 - periodic safety update report single assessment erdosteine	New
06/10/2026	Event: European Medicines Agency workshop on bacteriophage therapy	Updated
06/10/2026	Medicine: Usymro ustekinumab	Updated
06/10/2026	PSUSA: PSUSA/00001781/202601 - periodic safety update report single assessment ipratropium / salbutamol	New
06/10/2026	PSUSA: PSUSA/00001583/202602 - periodic safety update report single assessment haemophilus type b and meningococcal group C conjugate vaccine	New
06/10/2026	Medicine: Myalepta metreleptin	Updated
06/10/2026	Post-authorisation: Imfinzi - withdrawal of application for variation to marketing authorisation durvalumab	Updated
06/10/2026	PSUSA: PSUSA/00002951/202601 - periodic safety update report single assessment tick-borne encephalitis vaccine (inactivated)	New
06/10/2026	Medicine: Ruxience rituximab	Updated
06/10/2026	Event: Committee for Orphan Medicinal Products (COMP): 6-8 October 2026	Updated
06/10/2026	Document: Agenda of the COMP Meeting 6-8 October 2026	New
06/10/2026	Document: Product Management Service (PMS) - Frequently Asked Questions (FAQs)	Updated
06/10/2026	Event: Ninth European Medicines Agency (EMA) and EFPIA bilateral meeting	Updated
06/10/2026	Document: Records of data processing activity relating to the management and processing of documents related to absences due to illness or accident and consultations with the occupational health physicians	New
06/10/2026	Event: European platform for regulatory science research meeting: October 2026	Updated
06/10/2026	Page: Developing cancer medicines for children	Updated
06/10/2026	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure	Updated
06/10/2026	Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
06/10/2026	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure	Updated
06/10/2026	Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes	Updated
06/10/2026	Document: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical	Updated
06/10/2026	Page: Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union	Updated
06/10/2026	Page: Accelerated assessment	Updated
06/10/2026	Page: Periodic safety update reports (PSURs)	Updated
06/10/2026	Page: Type-II variations: questions and answers	Updated
06/10/2026	Page: Extensions of marketing authorisations: questions and answers	Updated
06/10/2026	Page: Type-IA variations: questions and answers	Updated
06/10/2026	Page: Changing the labelling and package leaflet (Article 61(3) notifications)	Updated
06/10/2026	Page: Pre-authorisation guidance	Updated
06/10/2026	Medicine: Filsuvez birch bark extract	Updated
06/10/2026	Event: Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026	Updated
06/10/2026	Document: Agenda of the CVMP meeting 6-8 October 2026	New
05/10/2026	Medicine: Byooviz ranibizumab	Updated
05/10/2026	Medicine: Ertapenem SUN ertapenem	Updated
05/10/2026	Medicine: Kinzalkomb telmisartan; hydrochlorothiazide	Updated
05/10/2026	Medicine: PritorPlus telmisartan; hydrochlorothiazide	Updated
05/10/2026	Medicine: Aumseqa Aumolertinib	Updated
05/10/2026	Medicine: Aimovig erenumab	Updated
05/10/2026	Document: Minutes of the CHMP meeting 15-18 September 2025	New
05/10/2026	Medicine: Hexacima diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Updated
05/10/2026	PSUSA: PSUSA/00011084/202603 - periodic safety update report single assessment dienogest / ethinylestradiol	New
05/10/2026	Medicine: Hexyon diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)	Updated
05/10/2026	Medicine: Opdualag relatlimab; nivolumab	Updated
05/10/2026	PSUSA: PSUSA/00000110/202601 - periodic safety update report single assessment alprostadil	New
05/10/2026	Document: Minutes of the CAT meeting 12-14 August 2026	New
05/10/2026	Document: Minutes of the CAT meeting 15-17 July 2026	New
05/10/2026	Document: User manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)	Updated
05/10/2026	Event: Second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection	Updated
05/10/2026	Event: First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting	Updated
02/10/2026	PSUSA: PSUSA/00002550/202601 - periodic safety update report single assessment propafenone	New
02/10/2026	Medicine: Orgovyx relugolix	Updated
02/10/2026	Medicine: Ziextenzo pegfilgrastim	Updated
02/10/2026	Event: Regulatory sandboxes: Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop	Updated
02/10/2026	Medicine: Arsenic trioxide Accord arsenic trioxide	Updated
02/10/2026	PIP: EMA/PE/0000302950 - paediatric investigation plan humanised IgG4 bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor A, long form	New
02/10/2026	PIP: EMA/PE/0000291645 - paediatric investigation plan mRNA encoding Human cytomegalovirus UL128; mRNA encoding Human cytomegalovirus UL130; mRNA encoding Human cytomegalovirus UL131A; mRNA encoding Human cytomegalovirus glycoprotein H; mRNA encoding Human cytomegalovirus glycoprotein B; mRNA encoding Human cytomegalovirus glycoprotein L	Updated
02/10/2026	Medicine: Rasilez aliskiren	Updated
02/10/2026	Medicine: Ordspono odronextamab	Updated
02/10/2026	Medicine: Sialanar glycopyrronium bromide	Updated
02/10/2026	Medicine: Andembry garadacimab	Updated
02/10/2026	Medicine: Sprycel dasatinib (anhydrous)	Updated
02/10/2026	Page: Procedural timetables	Updated
02/10/2026	Event: Committee for Herbal Medicinal Products (HMPC): 6-8 July 2026	Updated
02/10/2026	Document: List of centrally authorised products with safety-related changes to the product information	Updated
02/10/2026	News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October	New
02/10/2026	Medicine: Itvisma onasemnogene abeparvovec	Updated
02/10/2026	Medicine: Bysumlog insulin lispro	Updated
02/10/2026	EU-M4all: Ivermectin/Albendazole - opinion on medicine for use outside EU ivermectin; albendazole	Updated
02/10/2026	Event: Good manufacturing practice: Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)	Updated
02/10/2026	Medicine: Riltrava Aerosphere formoterol fumarate dihydrate; glycopyrronium; budesonide	Updated
02/10/2026	Medicine: Leqvio inclisiran	Updated
02/10/2026	Medicine: Ebvallo tabelecleucel	Updated
02/10/2026	Page: External whistleblowing policy	Updated
02/10/2026	Medicine: Byetta exenatide	Updated
02/10/2026	Document: Policy 72: Policy on the handling of information from external persons on breaches related to the authorisation, supervision and maintenance of human and veterinary medicinal products or other EMA activities	Updated
02/10/2026	Medicine: Bydureon exenatide	Updated
02/10/2026	Medicine: Adzynma rADAMTS13	Updated
01/10/2026	Medicine: Constella linaclotide	Updated
01/10/2026	Medicine: Sibnayal potassium citrate; potassium hydrogen carbonate	Updated
01/10/2026	Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party	Updated
01/10/2026	Document: Meeting summary - Medicine shortages SPOC working party meeting 15 July 2026	New
01/10/2026	Medicine: Degevma denosumab	Updated
01/10/2026	News: Advice on ‘end-of-year’ submission dates for type I variations in 2026	New
01/10/2026	News: EMA Management Board: highlights of September 2026 meeting	New
01/10/2026	Document: Proceedings for the nomination and appointment of the next EMA Executive Director	New
01/10/2026	Medicine: Epruvy (previously Ranibizumab Midas) ranibizumab	Updated
01/10/2026	Page: International Coalition of Medicines Regulatory Authorities (ICMRA)	Updated
01/10/2026	News: Global regulators call for advancing alternatives to animal testing across the medicine lifecycle	New
01/10/2026	Page: EudraVigilance: electronic reporting	Updated
01/10/2026	News: Executive Director speech at EMA women’s health multi-stakeholder workshop	New
01/10/2026	Medicine: Pomalidomide Teva pomalidomide	Updated

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