09.05.2016 - Notice within the graduated plan procedure (Stufenplanverfahren)

In its notice within the graduated plan procedure the BfArM revoked all marketing authorizations for fusafungin-containing medicinal products in Germany.

11.04.2016 - Hearing within the graduate plan procedure

BfArM intends to order the revocation of marketing authorizations for fusafungin-containing medicinal products following the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures (CMDh) on April 1, by way of a graduated plan procedure (Stufenplanverfahren) within the schedule adopted by the CMDh, effective May 28, 2016.

12.02.2016 - PRAC recommendation

BfArM informs about the recommendation of the PRAC in the procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing fusafungin (in Germany: Locabiosol® - spray for use in the oral cavity and nasal spray). The PRAC recommendation represents an important interim result, but is not yet legally binding.

11.09.2015 - Procedure started

The BfArM informs about the initiation of a European risk assessment procedure according to Article 31 of Directive 2001/83/EC on Fusafungin. The antibiotic derived from the fungus Fusarium lateritium is approved for the treatment of infections and inflammations of the upper respiratory tract.

Further information

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

Fusafungine containing medicinal products for oromucosal and nasal use