Vihuma

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simoctocog alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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’).

This EPAR was last updated on 15/01/2019

Authorisation details

Product details
Name
Vihuma
Agency product number
EMEA/H/C/004459
Active substance
simoctocog alfa
International non-proprietary name (INN) or common name
simoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Octapharma AB
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
13/02/2017
Contact address
Lars Forssells gata
23 112 75 Stockholm
Sweden

Product information

20/12/2018 Vihuma - EMEA/H/C/004459 - X/0006/G

Contents

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Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Vihuma can be used for all age groups.

Assessment history

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