Fosfomycin-containing medicinal products
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 9 June 2020, EMA recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from their prostate (biopsy).
EMA further recommended that fosfomycin medicines given by mouth to children (under 12 years of age) and intramuscular formulations (fosfomycin medicines for injection into a muscle) should no longer be used as there are insufficient data available to confirm their benefits to patients.
These recommendations follow a review by EMA’s human medicines committee (CHMP) of the safety and effectiveness of these antibiotics.
Fosfomycin was first discovered in 1969. Due in part to their limited use since their approval, fosfomycin antibiotics are still active against a number of bacteria that have become resistant to commonly used antibiotics. In recent years, this has led to an increase in the use of fosfomycin in patients with few other treatment options.
The review aimed to determine the place of fosfomycin in the treatment of infections, taking into account the latest available evidence. It concluded that:
- fosfomycin given into a vein should now only be used for treating certain serious infections such as those affecting the heart, lungs, blood and brain or those that are difficult to treat such as complicated infections of the abdomen, urinary tract, bone, joint or of the skin and soft tissue.
- fosfomycin, for use by mouth, can continue to be used for treating uncomplicated cystitis in women and adolescent girls. Fosfomycin granules (which contain fosfomycin trometamol) can also continue to be used in men undergoing biopsy of the prostate. EMA asked companies for further data to justify the continued use of oral medicines containing fosfomycin trometamol and fosfomycin calcium.
- intramuscular fosfomycin and fosfomycin granules for children (2 g) should be suspended as there is no clear evidence that they are sufficiently effective for their currently authorised uses.
Key facts
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About this medicine
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|---|---|
| Approved name |
Fosfomycin-containing medicinal products
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| International non-proprietary name (INN) or common name |
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| Associated names |
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| Class |
Antibiotics
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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-31/1476
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| Type | |
| Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
26/03/2020
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| EC decision date |
09/06/2020
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All documents
Procedure started
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Fosfomycin Article-31 referral - Annex V (PDF/95.53 KB)
First published: 06/07/2020
Fosfomycin Article-31 referral - Annex IV (PDF/125.41 KB)
First published: 06/07/2020
Fosfomycin Article-31 referral - Annex II (PDF/244.05 KB)
First published: 06/07/2020
Fosfomycin Article-31 referral - Assessment report (PDF/1.3 MB)
First published: 18/06/2020
EMA/229801/2020
Fosfomycin Article-31 referral - Annex III (PDF/470.38 KB)
First published: 31/03/2020
Last updated: 06/07/2020
Fosfomycin Article-31 referral - Annex I (PDF/374.3 KB)
First published: 14/12/2018
Last updated: 06/07/2020
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.
News
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27/03/2020
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27/03/2020
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14/12/2018