The approval under the European Workshare Procedure also covers use of Mirena for the treatment of idiopathic menorrhagia (heavy menstrual bleeding) for up to eight years, according to the pharma group.
The EU decision follows a green light from the FDA for longer-duration use of Mirena – an intrauterine device (IUD) that also delivers the hormone levonorgestrel – in August. It was first approved for five-year contraception back in 2000, and had that extended to seven years in 2021.
