Symbioflor 2

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


EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome

Medicine should no longer be used for other disorders of the gut

On 22 June 2017 a review by European Medicines Agency (EMA) concluded that Symbioflor 2 and associated names can continue to be used for treatment of irritable bowel syndrome (IBS) in adults. However, the medicine should no longer be used more widely to treat so-called functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches.

Symbioflor 2, which contains Escherichia coli bacteria, has been described as a probiotic, which means that it encourages the growth of beneficial organisms ('flora') in the gut. It was first made available in Germany in the 1950s and subsequently in Austria and Hungary.

In reaching its conclusions, EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed all available evidence on the effectiveness and safety of Symbioflor 2. The data included clinical studies, scientific publications, post-marketing experience, as well as information provided by the company and the views of an expert group formed for evaluating Symbioflor 2. The review did not find any new evidence on the effectiveness of Symbioflor 2 since the product was last approved. Available evidence suggests that the risk of harm from Symbioflor 2 is low.

A randomised study involving around 300 adults suggested that Symbioflor 2 was effective for treating IBS. However, the study had weaknesses. Benefit has not yet been established in children with IBS. Since the available data were not sufficiently robust for the CHMP to draw conclusions on how well Symbioflor 2 works and whether it is effective for any particular type of IBS, the CHMP has asked the company to carry out a well-designed study on effectiveness and safety among patients with different features of IBS (e.g. those with diarrhoea or with constipation as an important feature). Submission of the study report to national authorities will be a condition for maintaining Symbioflor 2's marketing authorisation.

The company that markets Symbioflor 2 did not submit data to support its use in 'functional gastrointestinal disorders' and agreed to remove this use from the medicine's authorisation. The CHMP recommendation was sent to the European Commission which issued a legally binding decision valid throughout the EU.

Key facts

Approved name
Symbioflor 2
International non-proprietary name (INN) or common name

Escherichia coli bacteria (cells and autolysate)

Associated names
  • Symbioflor E. Coli
  • Symbioflor® 2
  • Symbioflor Escherichia
Other immunostimulants, Antidiarrheal microorganisms
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
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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