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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.

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.

Results (209)

Date	Content	Status
29/08/2025	Medicine: Nintedanib Accord nintedanib	Updated
29/08/2025	Medicine: Darzalex daratumumab	Updated
29/08/2025	Medicine: Talzenna talazoparib	Updated
29/08/2025	Document: Minutes of the CAT meeting 11-13 June 2025	New
29/08/2025	Medicine: Nubeqa darolutamide	Updated
29/08/2025	Medicine: Vevzuo denosumab	Updated
29/08/2025	Medicine: Jeraygo aprocitentan	Updated
29/08/2025	Medicine: Spexotras trametinib	Updated
29/08/2025	Shortage: Dynastat parecoxib	Updated
28/08/2025	Medicine: Rivaroxaban Accord rivaroxaban	Updated
28/08/2025	Medicine: Zolgensma onasemnogene abeparvovec	Updated
28/08/2025	Document: Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks	New
28/08/2025	Medicine: Afinitor everolimus	Updated
28/08/2025	Page: Companion Diagnostic (CDx) Expert Group	New
28/08/2025	Medicine: Sarclisa isatuximab	Updated
27/08/2025	Medicine: Icatibant Accord icatibant	Updated
27/08/2025	Medicine: Tabrecta capmatinib	Updated
27/08/2025	Medicine: Laventair Ellipta (previously Laventair) umeclidinium bromide; vilanterol	Updated
27/08/2025	Medicine: Roteas edoxaban	Updated
27/08/2025	Medicine: Lixiana edoxaban	Updated
27/08/2025	Medicine: Kyntheum brodalumab	Updated
27/08/2025	Medicine: Itovebi inavolisib	Updated
27/08/2025	Shortage: Zypadhera olanzapine	Updated
27/08/2025	Medicine: Betmiga mirabegron	Updated
27/08/2025	Medicine: Pregabalin Accord pregabalin	Updated
27/08/2025	Event: 14th industry stakeholder platform on research and development support	Updated
27/08/2025	Document: Highlight report from the 14th Industry stakeholder platform on research and development support	New
27/08/2025	Document: Minutes - PDCO minutes of the 17-20 June 2025 meeting	New
27/08/2025	Medicine: Felisecto Plus selamectin; sarolaner	Updated
26/08/2025	Medicine: Iscover clopidogrel	Updated
26/08/2025	Medicine: Dimethyl fumarate Accord dimethyl fumarate	Updated
26/08/2025	Medicine: Ocrevus ocrelizumab	Updated
26/08/2025	Medicine: Zykadia ceritinib	Updated
26/08/2025	Medicine: Klisyri tirbanibulin	Updated
26/08/2025	Page: Assessment templates and guidance	Updated
26/08/2025	Page: Development of the Clinical Trials Information System	Updated
26/08/2025	Page: Clinical Trials Regulation: progress on implementation	Updated
26/08/2025	Shortage: Biltricide praziquantel	New
26/08/2025	Medicine: Winlevi clascoterone	Updated
25/08/2025	Medicine: Truqap capivasertib	Updated
25/08/2025	Medicine: Tyverb lapatinib	Updated
25/08/2025	Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – July 2025	Updated
25/08/2025	Medicine: Galafold migalastat	Updated
25/08/2025	Medicine: Rotarix rotavirus vaccine, live	Updated
22/08/2025	Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 July 2025 PRAC	Updated
22/08/2025	Medicine: Piqray alpelisib	Updated
22/08/2025	Medicine: Fanskya Mozafancogene autotemcel	New
22/08/2025	Medicine: Oczyesa octreotide	Updated
22/08/2025	Medicine: Vimkunya Chikungunya vaccine (recombinant, adsorbed)	Updated
21/08/2025	Medicine: Ninlaro ixazomib	Updated
21/08/2025	Medicine: Myalepta metreleptin	Updated
21/08/2025	Event: First webinar on new approach methodologies (NAMs) in ecotoxicology: State of the science for bioaccumulation	New
21/08/2025	Medicine: Trodelvy sacituzumab govitecan	Updated
21/08/2025	Medicine: Exjade deferasirox	Updated
21/08/2025	Medicine: Dasatinib Accord Healthcare dasatinib	Updated
21/08/2025	Medicine: Fampyra fampridine	Updated
21/08/2025	Medicine: Spevigo spesolimab	Updated
21/08/2025	Document: Public statement on Esmya: Withdrawal of the marketing authorisation in the European Union	Updated
21/08/2025	EU-M4all: Dapivirine Vaginal Ring 25 mg - opinion on medicine for use outside EU dapivirine	Updated
21/08/2025	Document: Vaccine Monitoring Platform: List of EMA-funded studies	Updated
21/08/2025	PSUSA: PSUSA00001858202409 - periodic safety update report single assessment levosimendan	New
21/08/2025	Medicine: Evfraxy denosumab	Updated
21/08/2025	DHPC: Evrysdi - direct healthcare professional communication (DHPC) risdiplam	New
20/08/2025	Medicine: Votubia everolimus	Updated
20/08/2025	Medicine: Esmya ulipristal	Updated
20/08/2025	Medicine: Raxone idebenone	Updated
20/08/2025	Medicine: Qaialdo spironolactone	Updated
20/08/2025	PSUSA: PSUSA/00001158/202411 - periodic safety update report single assessment domperidone	New
20/08/2025	Document: PRAC recommendations on signals adopted at the 7-10 July 2025 PRAC meeting	New
20/08/2025	Medicine: Rimmyrah ranibizumab	Updated
20/08/2025	Medicine: Opzelura ruxolitinib	Updated
20/08/2025	Medicine: Ezmekly mirdametinib	Updated
19/08/2025	Medicine: Usymro ustekinumab	Updated
19/08/2025	Medicine: Rystiggo rozanolixizumab	Updated
19/08/2025	Medicine: Aucatzyl obecabtagene autoleucel	Updated
19/08/2025	Medicine: Ultomiris ravulizumab	Updated
19/08/2025	Medicine: Invanz ertapenem	Updated
19/08/2025	Medicine: M-M-RVaxPro measles, mumps and rubella vaccine (live)	Updated
19/08/2025	Medicine: Venclyxto venetoclax	Updated
19/08/2025	Medicine: Shingrix herpes zoster vaccine (recombinant, adjuvanted)	Updated
19/08/2025	Document: European Medicines Agency’s data protection notice for the use of EMA Authentication Services and Microsoft Entra ID	New
19/08/2025	Document: Records of data processing activity for EMA Authentication Services and Microsoft Entra ID	New
19/08/2025	Medicine: Qdenga dengue tetravalent vaccine (live, attenuated)	Updated
19/08/2025	Medicine: Tyruko natalizumab	Updated
19/08/2025	Medicine: Paxlovid nirmatrelvir; ritonavir	Updated
19/08/2025	Document: CHMP PROM minutes for the meeting on 14 April 2025	New
19/08/2025	Document: Records of data processing activity for mail management	New
19/08/2025	Document: Minutes of the PRAC meeting 2-5 June 2025	New
18/08/2025	Document: QRD PSUR annex IV template	Updated
18/08/2025	Shortage: Moventig	New
18/08/2025	Event: Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA) November 2025	New
18/08/2025	Page: Veterinary Medicines	Updated
18/08/2025	Document: Organisation chart: Veterinary Medicines	Updated
18/08/2025	Page: ICH Q3E Extractables and leachables - scientific guideline	New
14/08/2025	Medicine: Fluenz Tetra influenza vaccine (live attenuated, nasal)	Updated
14/08/2025	Medicine: Sixmo buprenorphine	Updated
14/08/2025	Medicine: Keytruda pembrolizumab	Updated
14/08/2025	Medicine: Imjudo tremelimumab	Updated
14/08/2025	Document: Annex to 22-25 April 2025 CHMP Minutes	New
14/08/2025	Document: Minutes of the CHMP meeting 22-25 April 2025	New
14/08/2025	Document: CHMP PROM minutes for the meeting on 17 February 2025	New
14/08/2025	Page: Everolimus product-specific bioequivalence guidance	Updated
14/08/2025	Page: Deferasirox product-specific bioequivalence guidance	Updated
13/08/2025	Medicine: Jivi damoctocog alfa pegol	Updated
13/08/2025	PSUSA: PSUSA/00001789/202411 - periodic safety update report single assessment isoniazid	New
13/08/2025	Medicine: Amvuttra vutrisiran	Updated
13/08/2025	Medicine: Apixaban Accord apixaban	Updated
13/08/2025	Medicine: Breyanzi lisocabtagene maraleucel	Updated
13/08/2025	Medicine: Veklury remdesivir	Updated
13/08/2025	Medicine: Kovaltry octocog alfa	Updated
13/08/2025	Medicine: Exparel liposomal bupivacaine	Updated
13/08/2025	Medicine: Stribild elvitegravir; cobicistat; emtricitabine; tenofovir disoproxil	Updated
13/08/2025	Medicine: Wyost denosumab	Updated
13/08/2025	Medicine: Instanyl fentanyl	Updated
13/08/2025	Medicine: Ferriprox deferiprone	Updated
13/08/2025	News: EMA closed on 15 August for Assumption Day	New
13/08/2025	Medicine: Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) chenodeoxycholic acid	Updated
13/08/2025	Medicine: Enbrel etanercept	Updated
12/08/2025	Medicine: Dazublys trastuzumab	New
12/08/2025	Page: Good agricultural and collection practice for starting materials of herbal origin - Scientific guideline	Updated
12/08/2025	Document: Minutes of the COMP meeting 10-12 June 2025	New
12/08/2025	Document: Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products	Updated
12/08/2025	Medicine: Nurzigma pridopidine	Updated
12/08/2025	Medicine: Dyrupeg pegfilgrastim	Updated
12/08/2025	PSUSA: PSUSA/00002052/202410 - periodic safety update report single assessment Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide	New
12/08/2025	Medicine: Targretin bexarotene	Updated
12/08/2025	Medicine: Jelrix autologous cartilage-derived articular chondrocytes, in-vitro expanded	Updated
12/08/2025	Medicine: Naveruclif paclitaxel	Updated
12/08/2025	Medicine: Sogroya somapacitan	Updated
11/08/2025	Medicine: Zometa zoledronic acid	Updated
11/08/2025	Document: European Medicines Agency Write PMS API implementation Guide	Updated
11/08/2025	Document: European Medicines Agency Write PMS API implementation Guide (zip)	Updated
08/08/2025	Medicine: Jinarc tolvaptan	Updated
08/08/2025	Medicine: Cystadrops mercaptamine	Updated
08/08/2025	Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - tracked changes	Updated
08/08/2025	Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2	Updated
08/08/2025	Document: Paediatric investigation plan (PIP) - Key elements form	Updated
08/08/2025	Document: Procedural advice on paediatric applications	Updated
08/08/2025	Page: Paediatric medicines: applications and procedures	Updated
08/08/2025	Document: Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion	Updated
08/08/2025	Event: 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan	Updated
07/08/2025	Page: Emergency Task Force (ETF)	Updated
07/08/2025	Document: Composition of the Emergency Task Force (ETF) for preparedness	New
07/08/2025	Document: Superseded - Composition of the Emergency Task Force (ETF) for preparedness	Updated
07/08/2025	Medicine: LysaKare arginine; lysine	Updated
07/08/2025	Medicine: Brintellix vortioxetine	Updated
07/08/2025	Document: Applications for new human medicines under evaluation: August 2025	New
07/08/2025	Page: Vaccine Monitoring Platform	Updated
07/08/2025	Document: Medicine shortage communication (MSC): Zypadhera (olanzapine pamoate monohydrate <210 mg / 300 mg / 405 mg> powder and solvent for prolonged release suspension for injection)	New
07/08/2025	Document: Agenda - Multi-stakeholder workshop on tailored clinical approach for biosimilars	New
06/08/2025	Document: Ketoprofen: European public maximum-residue-limit assessment report (EPMAR) - CVMP	New
06/08/2025	Medicine: Zebinix eslicarbazepine acetate	Updated
06/08/2025	Medicine: Enurev Breezhaler glycopyrronium bromide	Updated
06/08/2025	Medicine: Adempas riociguat	Updated
06/08/2025	Page: Quality guidelines	Updated
06/08/2025	Document: Feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the feasibility of alternatives to replace titanium dioxide (TiO2) in medicinal products and its possible impact on medicines’ availability	New
06/08/2025	Document: Annex I - Use of titanium dioxide as excipient in human and veterinary medicines and identification of alternatives - Industry feedback to QWP experts / EMA questions - Final report February 2024	New
06/08/2025	Medicine: Tovanor Breezhaler glycopyrronium bromide	Updated
06/08/2025	Medicine: Seebri Breezhaler glycopyrronium bromide	Updated
06/08/2025	Page: Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific guideline	Updated
06/08/2025	Document: Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease	New
06/08/2025	Medicine: Fetcroja cefiderocol	Updated
06/08/2025	EU-M4all: Pyramax - opinion on medicine for use outside EU artesunate; pyronaridine	Updated
06/08/2025	Medicine: Kengrexal cangrelor	Updated
06/08/2025	Medicine: Tecentriq atezolizumab	Updated
06/08/2025	Document: Marketing authorisation application (MAA) - pre-submission interactions form	Updated
06/08/2025	Medicine: Ayvakyt avapritinib	Updated
05/08/2025	Document: CHMP-CAT - D80-210 Overview to final EPAR - Rev 07.25 Revamp	Updated
05/08/2025	Medicine: Riximyo rituximab	Updated
05/08/2025	Medicine: Omnitrope somatropin	Updated
05/08/2025	Medicine: Emtricitabine / Tenofovir alafenamide Viatris emtricitabine; tenofovir alafenamide	Updated
05/08/2025	Medicine: Livtencity maribavir	Updated
05/08/2025	PSUSA: PSUSA/00002013/202412 - periodic safety update report single assessment methocarbamol / paracetamol	New
05/08/2025	PSUSA: PSUSA/00002024/202410 - periodic safety update report single assessment methylphenidate	New
05/08/2025	PSUSA: PSUSA/00000997/202410 - periodic safety update report single assessment dexketoprofen	New
05/08/2025	Document: Declaration of interest form: Public call for Scientific Advisory Group on Immune and Inflammatory Diseases	New
05/08/2025	Medicine: Glivec imatinib	Updated
05/08/2025	Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 21-24 July 2025	New
04/08/2025	Medicine: Docetaxel Kabi docetaxel	Updated
04/08/2025	Medicine: Vitrakvi larotrectinib	Updated
04/08/2025	Medicine: Kalydeco ivacaftor	Updated
04/08/2025	Page: CHMP opinions on consultation procedures	Updated
04/08/2025	Event: 13th Industry Standing Group (ISG) meeting	Updated
04/08/2025	Document: Highlights - 13th Industry Standing Group (ISG) meeting	New
04/08/2025	Medicine: Rezolsta darunavir; cobicistat	Updated
04/08/2025	Document: Scientific advice and protocol assistance adopted during the CHMP meeting 21- 24 July 2025	New
04/08/2025	Document: List of industry subject matter experts and list of planned calls for industry subject matter experts	Updated
01/08/2025	Page: Plasma master file certificates	Updated
01/08/2025	PSUSA: PSUSA/00000830/202411 - periodic safety update report single assessment clotrimazole / dexamethasone	New
01/08/2025	PSUSA: PSUSA/00000831/202411 - periodic safety update report single assessment clotrimazole / hydrocortisone	New
01/08/2025	Document: Organisation chart: Information Management	Updated
01/08/2025	PSUSA: PSUSA/00010184/202406 - periodic safety update report single assessment rabbit anti-human thymocyte immunoglobulin	Updated
01/08/2025	Medicine: Bexsero meningococcal group B Vaccine (rDNA, component, adsorbed)	Updated
01/08/2025	Medicine: Enjaymo sutimlimab	Updated
01/08/2025	Page: Recommendations on medication errors	Updated
01/08/2025	DHPC: Rybelsus - direct healthcare professional communication (DHPC) semaglutide	New
01/08/2025	Medicine: Evkeeza evinacumab	Updated
01/08/2025	Event: Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines	Updated
01/08/2025	Medicine: Vyloy zolbetuximab	Updated
01/08/2025	Herbal: Combination: Species diureticae - herbal medicinal product Diuretic herbal tea combinations	Updated
01/08/2025	Document: Declaration of interests: Silvy da Rocha Dias	Updated
01/08/2025	Herbal: Fragariae folium - herbal medicinal product Wild Strawberry Leaf	Updated
01/08/2025	Herbal: Liquiritiae radix - herbal medicinal product Liquorice Root	Updated
01/08/2025	Document: Declaration of interests: Virginia Rojo Guerra	Updated
01/08/2025	Document: Declaration of interests: Karen Quigley	Updated
01/08/2025	Herbal: Cannabis flos - herbal medicinal product Cannabis flowering tops	Updated
01/08/2025	Page: Opinions and letters of support on the qualification of novel methodologies for medicine development	Updated
01/08/2025	Document: Overview of comments received on the draft qualification opinion for Simcyp Simulator	New
01/08/2025	Document: Qualification opinion for Simcyp Simulator	New

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Results (209)