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Dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne: use for treatment of acne possible if other specific treatments are not effective
2017.04.18
Active substance: dienogest, ethinylestradiol
05.04.2017 – Realisation of the EU Commission's implementing decision
Use should be limited to women who take oral contraceptive agents
In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing dienogest 2 mg und ethinylestradiol 0.03 mg is thus now concluded.
02.02.2017 – CHMP decision
The BfArM issues information on the EMA 's (European Medicines Agency) recommendation regarding treatment of moderate acne.
26.02.2016 – Procedure started
The BfArM issues information on the initiation of a European safety review regarding dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne.
Further information
For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):
Dienogest / Ethinylestradiol containing medicinal products indicated in acne
To the risk assessment procedure (available in German only)