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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 (100)

Date Content Status
06/08/2026
Medicine: Hyftor sirolimus
Updated
06/08/2026
Medicine: Tenkasi (previously Orbactiv) oritavancin
Updated
06/08/2026
Medicine: Docetaxel Kabi docetaxel
Updated
06/08/2026
Medicine: Synjardy empagliflozin; metformin
Updated
06/08/2026
Medicine: Zynlonta loncastuximab tesirine
Updated
06/08/2026
Medicine: Thiotepa Riemser thiotepa
Updated
06/08/2026
Medicine: Neuraceq florbetaben (18F)
Updated
06/08/2026
Medicine: Cholib fenofibrate; simvastatin
Updated
06/08/2026
Medicine: MabThera rituximab
Updated
06/08/2026
Medicine: Abrysvo respiratory syncytial virus vaccine (bivalent, recombinant)
Updated
06/08/2026
Medicine: Breyanzi lisocabtagene maraleucel
Updated
06/08/2026
Medicine: Idacio adalimumab
Updated
06/08/2026
Medicine: Firazyr icatibant
Updated
06/08/2026
Medicine: Tepkinly epcoritamab
Updated
06/08/2026
Medicine: Comirnaty COVID-19 mRNA vaccine
Updated
06/08/2026
Medicine: Cibinqo abrocitinib
Updated
06/08/2026
Medicine: Ozawade pitolisant
Updated
06/08/2026
Page: Expert panel support for breakthrough medical devices: pilot programme
 Updated
06/08/2026
Medicine: Deqtynet copper (64Cu) oxodotreotide
Updated
06/08/2026
Event: Quarterly System Demo - Q3 2026
 Updated
06/08/2026
Medicine: Spikevax (previously COVID-19 Vaccine Moderna) COVID-19 mRNA vaccine
Updated
06/08/2026
Document: Minutes - Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - July 2026
 New
06/08/2026
Referral: Tavneos - referral avacopan
Updated
06/08/2026
Page: Fees payable to the European Medicines Agency: Guidance for all applicants
 Updated
06/08/2026
Medicine: Wakix pitolisant
Updated
06/08/2026
DHPC: Desogestrel / etonogestrel - direct healthcare professional communication (DHPC) desogestrel; etonogestrel
New
05/08/2026
PSUSA: PSUSA/00000736/202509 - periodic safety update report single assessment choriogonadotropin alfa, chorionic gonadotrophin
New
05/08/2026
PSUSA: PSUSA/00000669/202512 - periodic safety update report single assessment chlorhexidine gluconate / isopropyl alcohol (covers other synonymous terms such as 2-propanol)
New
05/08/2026
Medicine: Degarelix Accord degarelix
Updated
05/08/2026
Medicine: Ninlaro ixazomib
Updated
05/08/2026
Medicine: Nexpovio selinexor
Updated
05/08/2026
Medicine: Kyprolis carfilzomib
Updated
05/08/2026
Medicine: Rolufta Ellipta (previously Rolufta) umeclidinium
Updated
05/08/2026
Medicine: Humira adalimumab
Updated
05/08/2026
Medicine: Leqembi lecanemab
Updated
05/08/2026
Medicine: Arikayce liposomal amikacin
Updated
05/08/2026
Medicine: Signifor pasireotide
Updated
05/08/2026
Medicine: Iqirvo elafibranor
Updated
05/08/2026
Medicine: Caprelsa vandetanib
Updated
05/08/2026
Medicine: Vantobra (previously Tobramycin PARI) tobramycin
Updated
05/08/2026
Medicine: Kisqali ribociclib
Updated
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