Re-evaluation of the effectiveness of emergency contraception "morning-after pill" started
The European Medicines Agency (EMA) has initiated an Article 31 procedure under Directive 2001/83 EC to assess whether higher body weight or a higher body mass index could lead to reduced efficacy of the "morning-after pill" preparations approved in Austria or Europe. "Morning-after pill" preparations are used for emergency contraception to prevent pregnancy after unprotected sexual intercourse or failure of a contraceptive method. The products concerned are levonorgestrel-containing preparations (Vikela, Postinor) and an ulipristal-containing preparation (ellaOne).
The following medicinal products are approved in Austria: Vikela 750 microgram tablets Vikela 1.5 mg tablet Postinor 1500 microgram tablet ellaOne 30 mg tablet.
The EMA's Committee for Medicinal Products for Human Use is currently evaluating whether to make appropriate changes to the SmPC and package leaflet of the affected medicines and, once the evaluation is complete, will submit the outcome to the European Commission for regulatory clearance. Further information: European Medicines Agency press release (Jan. 24, 2014).
Queries (technical): Dr. Christoph Baumgärtel, Tel: 050555/36004 Email: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
