German pharmaceutical company Bayer AG (BAYZF.PK,BAYRY.PK,BYR.L) announced Friday that Mirena (52mg LNG IUS), its long-acting reversible intrauterine system, received regulatory approval in the European Workshare Procedure for up to eight years in contraception. This is the longest contraceptive duration of use for any hormonal intrauterine system.
The levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena has been approved 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 the fourth quarter of 2022.
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.
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.
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