Adjustments to medicinal product information and risk minimization measures for medicinal products containing the active substances cyproterone acetate and ethinyl estradiol
Summaries of the product characteristics and package leaflets of medicinal products containing cyproterone acetate and ethinyl estradiol will be aligned with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) endorsed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The recommendations are based on an assessment of the risks and benefits of the said medicinal products, published on the Agency for Medicinal Products and Medical Devices web site on 23 May 2013.
In the Republic of Croatia, marketing authorization has been granted for the following cyproterone- and ethinylestradiol-containing medicines:
1. Diane-35 coated tablets, marketing authorization holder Bayer d.o.o.
2. Bellune 35 coated tablets, marketing authorization holder Pliva Hrvatska d.o.o.
3. Axira 35 film coating tablets, marketing authorization holder Farmal d.d.
Detailed information can be found in the continuation of this notice.