Octagam
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
The European Medicines Agency has completed a review of Octagam and associated names that was triggered by reports of serious thromboembolic events in patients using the medicine. The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the EU-wide suspension of the marketing authorisation for Octagam be lifted subject to certain conditions, including a change to the medicine's manufacturing process.
Key facts
Approved name |
Octagam
|
International non-proprietary name (INN) or common name |
human normal immunoglobulin 5% and 10% |
Reference number |
EMEA/H/A-31/001281
|
Type | |
Status |
European Commission final decision
|
Opinion date |
14/04/2011
|
EC decision date |
30/05/2011
|
All documents
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List item
Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%) (PDF/120.39 KB)
Adopted
First published: 14/04/2011
Last updated: 19/11/2013
EMA/293780/2011 rev.1 -
-
List item
Octagam Article-31 referral - Assessment report (PDF/144.84 KB)
First published: 19/11/2013
Last updated: 19/11/2013
Document description
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies