03.07.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the EU Commission's implementing decision C(2020) 3966 of June 9, 2020, concerning marketing authorizations for medicinal products for human use containing the active substance fosfomycin, by decision of June 29, 2020.

27.03.2020 - CHMP opinion

The European Medicines Agency (EMA) has recommended that fosfomycin-containing drugs administered by infusion (drip) into a vein should be used to treat serious infections only when other antibiotic treatments are considered inappropriate.

14.12.2018 - Procedure started

The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/ EC for fosfomycin.
On the initiative of the Federal Institute for Drugs and Medical Devices (BfArM), the European Medicines Agency (EMA) has launched a procedure in its Committee for Medicinal Products for Human Use (CHMP) to scientifically reevaluate these drugs in view of their increasing resistance to antibiotics.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Fosfomycin-containing medicinal products