Bayer Mirena approved in Europe for extended duration of use in contraception
Berlin: Bayer has announced that it has positively concluded the European Workshare Procedure extending the duration of use for up to eight years in contraception of its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena for countries in Europe.
This regulatory approval in Europe is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of Mirena which demonstrated that contraceptive efficacy remains high with greater than 99% during years six to eight of use. Following the completion of the European Workshare procedure the first national approvals in the EU are expected in Q4 2022.
"With the positive clearance of the approval process in Europe we are pleased to be able to offer soon the extended label also to women in Europe, and with this enriching the range of contraceptive methods as individual contraceptive needs are changing throughout the reproductive life", said Dr. Michael Devoy, Chief Medical Officer at Bayer AG.
The European approval also includes symptom-driven extended use for the indication idiopathic menorrhagia (heavy menstrual bleeding) for up to eight years or until symptoms return. The IUS should be removed or replaced after eight years at the latest.
Read also: Trial evaluates contraceptive efficacy of Mirena Intrauterine System through 8 years
In August 2022, Bayer received U.S. approval for the extended duration of use for up to eight years in the contraception indication for its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena.
A LNG-IUS is one of the most effective birth control methods as it does not require user compliance such as daily dosing or monthly re-fills. It can be removed by the doctor at any time and offers a rapid return to a woman's natural level of fertility after removal. A LNG-IUS should only be inserted after a comprehensive discussion and evaluation of all contraceptive options and the individual woman's needs.
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