Vihuma
simoctocog alfa
Table of contents
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’).
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List item
Vihuma : EPAR - Medicine overview (PDF/75.08 KB)
First published: 12/04/2017
Last updated: 15/01/2019
EMA/851078/2018 -
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Vihuma : EPAR - Risk-management-plan summary (PDF/254.22 KB)
First published: 05/01/2022
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 | |
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Marketing-authorisation holder |
Octapharma AB
|
Revision |
8
|
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
13/10/2022 Vihuma - EMEA/H/C/004459 - WS2244
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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.