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Active substance: fluoroquinolones | quinolones
In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.
The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2018)2050 final of 11 March 2019 by decision of 28 March 2019.
The European Medicines Agency (EMA) has scientifically re-evaluated the serious, life-threatening and potentially persistent side effects associated with the group of fluoroquinolones and quinolones taken orally, injected or inhaled.
PRAC recommends restrictions of use due to the quality of life restricting and possibly long-lasting side effects.
The European Medicines Agency (EMA) has opened registration for the public hearing that will take place in June 2018.
The Pharmacovigilance Risk Assessment Committee (PRAC) has decided to organise a public hearing as part of the evaluation of fluoroquinolones and quinolones in order to hear directly the experience of interested parties so that they can be included in the Committee's recommendation.
The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/EC for antibiotics from the group of fluoroquinolones and quinolones.
For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):
BfArM - press release (available in German only)