Approval · Notice of Compliance 11373 · 2010
MIRENA: Notice of Compliance 11373
Issued May 11, 2010
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 11373
- Date
- May 11, 2010
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: treatment of idiopathic menorrhagia following appropriate diagnostic investigation in women accepting the contraceptive effect of Mirena
- Therapeutic class
- Progestogen
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MIRENA | Not yet assigned | — |
Medicinal ingredients
- LEVONORGESTREL 52 MG per UNIT