Octagam - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Octagam triggered by reports of serious thromboembolic events. The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all marketing authorisations for the medicine be suspended throughout the European Union (EU) and that Octagam currently on the market be recalled.

What is Octagam?

Octagam is a solution for infusion (drip into a vein) that contains human normal immunoglobulin extracted from blood as the active substance. Human normal immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.

Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS). It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.

Octagam is made by Octopharma. It is authorised in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.

Why was Octagam reviewed?

In September 2010, the German and Swedish medicines regulatory agencies suspended marketing authorisations for Octagam. This follows an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients taking the medicine. These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).

As required by Article 107, the German and Swedish agencies informed the CHMP of their actions so
that the Committee could prepare an opinion on whether the marketing authorisations for Octagam
should be maintained, changed, suspended or withdrawn across the EU.

Which data has the CHMP reviewed?

The CHMP reviewed the reported thromboembolic events and looked at evidence related to the
medicine's safety.

What are the conclusions of the CHMP?

The CHMP noted that, based on the available information, there was clear evidence of a recent
increase in thromboembolic events associated with Octagam but that the exact cause of the problems
could not be identified with certainty. The CHMP therefore recommended that, because of the safety
concerns with Octagam, the marketing authorisations for the medicine be suspended in the EU. While
the marketing authorisations are suspended, Octagam will not be available. The suspension will remain
in place until the problem has been rectified.

What are the recommendations for prescribers and patients?

• Doctors should stop using Octagam and switch their patients to the most appropriate alternative treatment.
• Patients who have any questions should speak to their doctor or pharmacist.

Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)

Adopted Reference Number: EMA/588737/2010

Key facts

About this medicine

• Approved name:
  Octagam
• International non-proprietary name (INN) or common name:
  human normal immunoglobulin
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-107/001278
• Type:
  Article 107 procedures (prior to July 2012)

  This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i.

Key dates and outcomes

• CHMP opinion date:
  23/09/2010
• EC decision date:
  04/10/2010

All documents

Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)

Adopted Reference Number: EMA/588737/2010

European Commission final decision

Article 107 referral - Assessment report for Octagam 5% and Octagam 10% medicinal products

Adopted Reference Number: EMA/331530/2013

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.