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
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20/12/2018 Vihuma - EMEA/H/C/004459 - X/0006/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Vihuma can be used for all age groups.