Symbioflor 2
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
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
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About this medicine
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| Approved name |
Symbioflor 2
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| International non-proprietary name (INN) or common name |
escherichia coli bacteria (cells and autolysate)
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| Associated names |
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| Class |
Other immunostimulants, Antidiarrheal microorganisms
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About this procedure
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| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1441
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| Type | |
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Key dates and outcomes
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| EC decision date |
22/06/2017
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All documents
Procedure started
Symbioflor 2 Article-31 referral - Annex I (PDF/24.9 KB)
First published: 06/04/2016
Last updated: 07/09/2017
Symbioflor 2 Article-31 referral - Notification (PDF/116.73 KB)
First published: 06/04/2016
Last updated: 06/04/2016
Symbioflor 2 Article-31 referral - CHMP list of questions (PDF/77.9 KB)
First published: 06/04/2016
Last updated: 06/04/2016
EMA/CHMP/233295/2016
Symbioflor 2 Article-31 referral - Timetable for the procedure (PDF/72.39 KB)
First published: 06/04/2016
Last updated: 24/03/2017
EMA/CHMP/233611/2016 Rev.5
Symbioflor 2 Article-31 referral - Review started (PDF/72.43 KB)
First published: 01/04/2016
Last updated: 01/04/2016
EMA/233358/2016
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Symbioflor 2 Article-31 referral - CHMP assessment report (PDF/976.72 KB)
First published: 07/09/2017
Last updated: 07/09/2017
EMA/530965/2017
Symbioflor 2 Article-31 referral - Annex II (PDF/68.44 KB)
First published: 07/09/2017
Last updated: 07/09/2017
Symbioflor 2 Article-31 referral - Annex IV (PDF/29.21 KB)
First published: 07/09/2017
Last updated: 07/09/2017
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.