Octagam

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
14/04/2011
EC decision date
30/05/2011

All documents

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:

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