European Medicines Agency to review Diane -35 and its generics

Notice type: Advisory

Date: 31/01/2013

 

Product name or type:
Diane 35* (ethinylestradiol and cyproterone acetate) *This medicine is marketed under the brand name Dianette in Ireland


Problem Or Issue:
The European Medicines Agency (EMA) has indicated that the French medicines regulatory authority (ANSM) will request an EU wide review of Diane 35 and its generics. This review will assess the benefits and risks of these medicines and will consider any impact on their marketing authorisations.  The EMA has indicated that this review will commence next week, following formal notification. Pending the outcome of the review, women who are currently taking Dianette or one of its generics are advised not to stop the medicine. If a woman has concerns, she can discuss this with her doctor.


Background Information Or Related Documents:
See the link to the EMA press release below:
EMA update on Diane 35 and generics used in the treatment of acne

European Medicines Agency to review Diane -35 and its generics Document


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