FDA — authorised 6 December 2000
- Application: NDA021225
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MIRENA
- Indication: SYSTEM — INTRAUTERINE
- Status: approved
🇺🇸 Levonorgestrel-releasing intrauterine system in United States
FDA authorised Levonorgestrel-releasing intrauterine system on 6 December 2000
Marketing authorisations
FDA
- Status: approved
Levonorgestrel-releasing intrauterine system in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Levonorgestrel-releasing intrauterine system approved in United States?
Yes. FDA authorised it on 6 December 2000; FDA has authorised it.
Who is the marketing authorisation holder for Levonorgestrel-releasing intrauterine system in United States?
BAYER HLTHCARE holds the US marketing authorisation.