Vihuma is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance simoctocog alfa (human coagulation factor VIII).
This medicine is the same as Nuwiq, which is already authorised in the EU. The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent’).
Vihuma : EPAR - Medicine overview (PDF/75.08 KB)
First published: 12/04/2017
Last updated: 15/01/2019
Vihuma : EPAR - Risk-management-plan summary (PDF/254.22 KB)
First published: 05/01/2022
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Lars Forssells gata
23 112 75 Stockholm
13/10/2022 Vihuma - EMEA/H/C/004459 - WS2244
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Vihuma can be used for all age groups.