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HIGHLIGHTS OF PRESCRIBING INFORMATION These …
NDA 21225 Mirena FDA Approved 08 June 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use MIRENA safely and effectively. See full PRESCRIBING INFORMATION for MIRENA. MIRENA (levonorgestrel-releasing intrauterine system) Initial Approval: 2000 ----------------------------RECENT MAJOR CHANGES-------------------------- Indications and Usage, Mirena is recommended for women who have had at least one child. Removed (1) 6/2017 Dosage and Administration, Timing of insertion ( ) 5/2017 ----------------------------INDICATIONS AND USAGE--------------------------- Mirena is a progestin-containing intrauterine system indicated for: Intrauterine contraception for up to 5 years (1) Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception.
HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use MIRENA safely and effectively. See full prescribing information for MIRENA. MIRENA (levonorgestrel-releasing intrauterine system) Initial U.S. Approval: 2000 -----RECENT MAJOR CHANGES-----
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