Nuwiq Octapharma AB · Authorised · authorised 22 Jul 2014 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq can be used for all age groups.
Active substance
Simoctocog alfa
- EMA 2
- Safety 2
EMA European Union — centrally authorised medicines
Vihuma Octapharma AB · Authorised · authorised 13 Feb 2017 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Vihuma can be used for all age groups.
Safety signals and safety-related labeling changes
- EMA PRAC 8 Feb 2018 PRAC signal: Inhibitor development in previously untreated patients (PUPs) with haemophilia A treated with plasma-derived vs recombinant coagulation factor VIII concentrates
Action for MAH: update of the product information: No - EMA PRAC 8 Jul 2016 PRAC signal: Inhibitor development in previously untreated patients (PUPs) with haemophilia A treated with plasma-derived vs recombinant coagulation factor VIII concentrates
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.