Vihuma

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simoctocog alfa

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

Overview

This is a summary of the European public assessment report (EPAR) for Vihuma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vihuma.

For practical information about using Vihuma, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/04/2017

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 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
0
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

13/02/2017 Vihuma - EMEA/H/C/004459 - -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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