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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 (59)

Date	Content	Status
04/08/2026	Medicine: Loqtorzi toripalimab	Updated
04/08/2026	Medicine: Silapo epoetin zeta	Updated
04/08/2026	Medicine: Elmiron pentosan polysulfate sodium	Updated
04/08/2026	Medicine: Obodence denosumab	Updated
04/08/2026	Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)	Updated
04/08/2026	Orphan: EU/3/19/2183 - orphan designation for treatment of WHIM syndrome mavorixafor	Updated
04/08/2026	Medicine: Dzuveo sufentanil	Updated
04/08/2026	Medicine: Vyxeos liposomal (previously Vyxeos) daunorubicin; cytarabine	Updated
04/08/2026	Orphan: EU/3/26/3201 - orphan designation for treatment of mesothelioma Measles virus Schwarz strain (live, attenuated)	Updated
04/08/2026	Orphan: EU/3/24/3012 - orphan designation for treatment of hepatitis delta virus infection tobevibart	Updated
04/08/2026	Orphan: EU/3/24/3010 - orphan designation for treatment of hepatitis delta virus infection elebsiran	Updated
04/08/2026	Orphan: EU/3/21/2475 - orphan designation for treatment of achondroplasia Infigratinib	Updated
04/08/2026	Medicine: Qinlock ripretinib	Updated
04/08/2026	Orphan: EU/3/15/1450 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine tumours Gallium (68Ga)-edotreotide	Updated
04/08/2026	Orphan: EU/3/07/523 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine tumours Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide (lutetium (177Lu) oxodotreotide)	Updated
04/08/2026	Orphan: EU/3/25/3118 - orphan designation for treatment of primary hyperoxaluria mRNA encoding Cas12HF endonuclease, Single guide RNA against the human HAO1 gene	Updated
04/08/2026	Orphan: EU/3/25/3032 - orphan designation for treatment of Olmsted syndrome (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl)pyrrolidin-1-yl)(5-hydroxy-6-methylpyridin-2-yl)methanone	Updated
04/08/2026	Orphan: EU/3/20/2286 - orphan designation for treatment of soft tissue sarcoma autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4	Updated
04/08/2026	Medicine: SomaKit TOC edotreotide	Updated
04/08/2026	Page: United for health at WorldPride 2026	New
04/08/2026	Medicine: Orserdu elacestrant	Updated
04/08/2026	Medicine: Vitrakvi larotrectinib	Updated
04/08/2026	Medicine: Skyclarys omaveloxolone	Updated
04/08/2026	Medicine: Spinraza nusinersen	Updated
04/08/2026	PSUSA: PSUSA/00003186/202511 - periodic safety update report single assessment a-tocopheril, a-tocopherol, vitamin E	New
04/08/2026	Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment	Updated
04/08/2026	Document: Retinal stimulation systems - Notified Body 0344 - 12/06/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)	New
04/08/2026	Medicine: Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) irbesartan; hydrochlorothiazide	Updated
04/08/2026	Medicine: Leflunomide medac leflunomide	Updated
04/08/2026	Medicine: Twinrix Adult hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)	Updated
04/08/2026	Medicine: Orblid bevacizumab	Updated
04/08/2026	Orphan: EU/3/14/1262 - orphan designation for prevention of bronchopulmonary dysplasia recombinant human surfactant protein D	Updated
04/08/2026	Page: Enpr-EMA priority activities	Updated
04/08/2026	Document: Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 June 2026	New
04/08/2026	Page: Plasma master file certificates	Updated
04/08/2026	Orphan: EU/3/16/1694 - orphan designation for treatment of soft tissue sarcoma autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1	Updated
04/08/2026	Document: Silapo : EPAR - All Authorised presentations	Updated
03/08/2026	Medicine: Vabysmo faricimab	Updated
03/08/2026	Medicine: Clopidogrel Zentiva (previously Clopidogrel Winthrop) clopidogrel	Updated
03/08/2026	Medicine: Takhzyro lanadelumab	Updated
03/08/2026	Medicine: Lytenava bevacizumab	Updated
03/08/2026	Medicine: Opzelura ruxolitinib	Updated
03/08/2026	Medicine: Palsonify paltusotine	Updated
03/08/2026	Medicine: Ambirix hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)	Updated
03/08/2026	Medicine: Twinrix Paediatric hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)	Updated
03/08/2026	Referral: Veterinary medicinal products containing albendazole as a single active substance presented as oral suspension in sheep - referral albendazole	Updated
03/08/2026	Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2026 PRAC	New
03/08/2026	Document: European Union Member State Public Holidays Recorded in CTIS (year: 2027)	New
03/08/2026	Medicine: Svariya (previously Rivaroxaban Koanaa) rivaroxaban	Updated
03/08/2026	Event: Enpr-EMA Coordinating Group meeting June 2026	New
03/08/2026	Document: PRAC recommendations on signals adopted at the 6-9 July 2026 PRAC meeting	New
03/08/2026	Document: List of signals discussed at PRAC since September 2012	Updated
03/08/2026	Document: Breakthrough status request: Template for applicants for breakthrough medical devices pilot	Updated
03/08/2026	Event: European platform for regulatory science research meeting: October 2026	New
03/08/2026	Event: Fifth European Medicines Agency (EMA) and Affordable Medicines Europe bilateral meeting	New
03/08/2026	Event: Ninth European Medicines Agency (EMA) and EFPIA bilateral meeting	New
03/08/2026	Page: Veterinary Medicines	Updated
03/08/2026	Document: Organisation chart: Veterinary Medicines	Updated
03/08/2026	Document: Organisation chart: Advisory functions	Updated

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Results (59)