Kovaltry

Glavne informacije

  • Zaščiteno ime:
  • Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje
  • Farmacevtska oblika:
  • prašek in vehikel za raztopino za injiciranje
  • Sestava:
  • koagulacijski faktor VIII, humani, rekombinantni 3000 i.e. / 1 viala
  • Pot uporabe:
  • Intravenska uporaba
  • Enote v paketu:
  • škatla z 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo s 5 ml vehikla, batom brizge, adaptejem za vialo in 1 priborom za ve
  • Tip zastaranja:
  • H/Rp - Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v bolnišnicah. Izjemoma se lahko uporablj
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • koagulacijski faktor VIII

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1024-12/2016-4
  • Datum dovoljenje:
  • 03-03-2016
  • EAN koda:
  • 3837000161960
  • Zadnja posodobitev:
  • 25-05-2018

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety