Iblias
octocog alfa
Table of contents
Overview
The marketing authorisation for Iblias has been withdrawn at the request of the marketing-authorisation holder.
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List item
Iblias : EPAR - Summary for the public (PDF/664.7 KB)
First published: 09/03/2016
Last updated: 09/03/2016
EMEA/H/C/004147 -
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List item
Iblias : EPAR - Risk-management-plan summary (PDF/615.14 KB)
First published: 09/03/2016
Last updated: 09/03/2016
EMA/1562/2016
Authorisation details
| Product details | |
|---|---|
| Name |
Iblias
|
| Agency product number |
EMEA/H/C/004147
|
| Active substance |
octocog alfa
|
| International non-proprietary name (INN) or common name |
octocog 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 |
Bayer AG
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/02/2016
|
| Contact address |
51368 Leverkusen |
Product information
10/11/2017 Iblias - EMEA/H/C/004147 - A31/0002
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).
Iblias can be used for all age groups.