• Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


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
International non-proprietary name (INN) or common name

human normal immunoglobulin 5% and 10%

Reference number
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.

European Commission final decision
Opinion date
EC decision date

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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