EU approves Kyleena (levonorgestrel-releasing intrauterine system) to prevent pregnancy- Bayer HealthCare
The EU has approved marketing of Kyleena (levonorgestrel-releasing intrauterine system) from Bayer HealthCare to prevent pregnancy. The product was approved by the FDA in September 2016, on the basis of data showing a very low rate of pregnancy rate in women who used Kyleena.
However, 22 percent of women discontinued the therapy due to adverse events, because of increased bleeding (4.5 percent), abdominal pain/pelvic pain (4.2 percent), device expulsion (3.1 percent), acne/seborrhea (2.3 percent), and dysmenorrhea/uterine spasm (1.3 percent). National EU authorities will now issue marketing authorisations in the coming weeks and months.
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