Newsfeed der Europäischen Kommission aus dem Union Register für Medizinprodukte:

• Yorvipath (Ascendis Pharma Bone Diseases A/S)
  17.11.2023
  Yorvipath (Active substance: palopegteriparatide) – New authorisation – Commission Decision (2023)8037 of Fri, 17 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005934/0000
• Ebglyss (Almirall S.A.)
  16.11.2023
  Ebglyss (Active substance: lebrikizumab) – New authorisation – Commission Decision (2023)7952 of Thu, 16 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005894/0000
• Dovprela (Mylan IRE Healthcare Limited)
  15.11.2023
  Dovprela (Active substance: pretomanid) – New authorisation – Commission Decision (2023)7928 of Wed, 15 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005167/II/0013
• Finlee (Novartis Europharm Limited)
  15.11.2023
  Finlee (Active substance: dabrafenib) – New authorisation – Commission Decision (2023)7926 of Wed, 15 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005885/0000
• AQUMELDI (Proveca Pharma Limited)
  15.11.2023
  AQUMELDI (Active substance: enalapril maleate) – New authorisation – Commission Decision (2023)7919 of Wed, 15 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005731/0000
• Catiolanze (Santen Oy)
  15.11.2023
  Catiolanze (Active substance: latanoprost) – New authorisation – Commission Decision (2023)7900 of Wed, 15 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005933/0000
• Herwenda (Sandoz GmbH)
  15.11.2023
  Herwenda (Active substance: trastuzumab) – New authorisation – Commission Decision (2023) 7893 of Wed, 15 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005769/0000
• VANFLYTA (Daiichi Sankyo Europe GmbH)
  06.11.2023
  VANFLYTA (Active substance: quizartinib) – New authorisation – Commission Decision (2023)7624 of Mon, 06 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005910/0000
• Tremelimumab AstraZeneca (AstraZeneca AB)
  06.11.2023
  Tremelimumab AstraZeneca (Active substance: tremelimumab) – Withdrawal – Commission Decision (2023)7611 of Mon, 06 Nov 2023
• Ninlaro (Takeda Pharma A/S)
  03.11.2023
  Ninlaro (Active substance: ixazomib) – New authorisation – Commission Decision (2023)7588 of Fri, 03 Nov 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/003844/II/0045
• Jaypirca (Eli Lilly Nederland B.V.)
  30.10.2023
  Jaypirca (Active substance: pirtobrutinib) – New authorisation – Commission Decision (2023) 7503 of Mon, 30 Oct 2023 – European Medicines Agency (EMA) procedure number: EMEA/H/C/005863/0000
• Clopidogrel BGR (Laboratoires BIOGARAN)
  26.10.2023
  Clopidogrel BGR (Active substance: Clopidogrel) – Withdrawal – Commission Decision (2023)7439 of Thu, 26 Oct 2023
• Ivozall (ORPHELIA Pharma SAS)
  18.10.2023
  Ivozall (Active substance: clofarabine) – Withdrawal – Commission Decision (2023)7140 of Wed, 18 Oct 2023
• Rebetol (Merck Sharp & Dohme B.V.)
  18.10.2023
  Rebetol (Active substance: ribavirin) – Withdrawal – Commission Decision (2023)7149 of Wed, 18 Oct 2023
• Ciambra (Menarini International Operations Luxembourg S.A.)
  12.10.2023
  Ciambra (Active substance: pemetrexed) – Withdrawal – Commission Decision (2023)7012 of Thu, 12 Oct 2023