October 4, 2023

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Bayer intrauterine device Mirena: FDA approved the renewal of the label

Bayer intrauterine device Mirena: FDA approved the renewal of the label

Bayer intrauterine device Mirena: FDA approved the renewal of the label. 

Place it once, contraceptive for 7 years! The US FDA approves the renewal of the label of the Bayer intrauterine device Mirena: the use period is extended to 7 years!

Updated label: Mirena has a contraceptive use period of 7 years and a treatment period of menorrhagia for 5 years.

Bayer is a leader in the field of women’s health care. The company recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplementary new drug application (sNDA). ), its market-leading intrauterine device (IUD) Mirena (Chinese trade name: Mirena, levonorgestrel intrauterine birth control system) 52mg expiry ) The continuous use time is extended to 7 years. The approval is based on the results of a phase 3 extended trial evaluating the effectiveness and safety of Mirena.

John Berrios, senior vice president of Bayer Women’s Health, said: “In keeping with our mission of supporting women, Bayer continues to take measures to promote women’s health. Providing 7 years of contraceptive options is an exciting milestone and another example of our commitment to women. There are more options to discuss with healthcare professionals to help them live their lives,”

Mirena was approved by the US FDA in 2020 and is the first hormone intrauterine device approved for use in the US market. It has been approved to release a small amount of progestin called levonorgestrel into the uterus to prevent pregnancy for up to 6 years . This product is also the only FDA-approved IUD for women who choose intrauterine birth control to treat menorrhagia for up to 5 years. This IUD can be used regardless of whether they have given birth before or not. Mirena is a long-acting reversible contraceptive product (LARC). If a woman’s plan changes, the medical institution can take it out at any time.

Currently, Mirena (levonorgestrel intrauterine birth control system) 52mg is used to prevent pregnancy for up to 7 years; it is replaced after the 7th year. For women who choose to use intrauterine birth control as a contraceptive method, Mirena can be used to treat menorrhagia for up to 5 years; if it is necessary to continue to treat menorrhagia, it will be replaced after the end of the fifth year.

Mirena is a small and flexible T-shaped stent that slowly releases progesterone in the uterine cavity. This product was approved in China for contraception and idiopathic menorrhagia in 1998. There are more than 100 million people worldwide. Female use. In June 2020, the State Food and Drug Administration approved an update on the indications of Mirena: “Menorrhoea. For patients with structural menorrhagia, priority should be given to the treatment of the primary disease.” Mirena provides an effective non-surgical option for the treatment of menorrhagia.

(source:internet, reference only)

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