Fosfomycin-containing medicinal products

Current status:
Procedure started

Overview

EMA begins review of medicines containing fosfomycin

EMA has started a review of medicines containing the antibiotic fosfomycin, which is used in a number of EU Member States to treat a range of bacterial infections.

Fosfomycin, an antibiotic that has been in use for many decades, works in a unique way and bacteria resistant to other antibiotics are less likely to be resistant to fosfomycin. There are significant differences between Member States in the authorised uses and doses of fosfomycin medicines. The German medicines authority has requested reappraisal of the role of fosfomycin in the context of increasing resistance to antibiotics. In particular, the indications and dosage of fosfomycin and the adequacy of information on its safety and pharmacological properties will be re-evaluated in the light of up-to-date knowledge on antibacterial therapy.

EMA’s human medicines committee (CHMP) will therefore consider the available evidence and make recommendations as to whether the marketing authorisations for fosfomycin-containing medicines should be amended across the EU.

Key facts

Approved name
Fosfomycin-containing medicinal products
International non-proprietary name (INN) or common name

fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol

Class
Antibiotics
Reference number
EMEA/H/A-31/1476
Type
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.

Status
Procedure started
Opinion date
13/12/2018

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:

News

Computed date field:
Friday, 14 December, 2018 - 12:32

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