Approval · Notice of Compliance 16256 · 2014
MIRENA: Notice of Compliance 16256
Issued October 10, 2014
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
- 16256
- Date
- October 10, 2014
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Modification of the inserter. modification of the sterilization process. change in the material composition of primary packaging. minor modifications to the t-body design and thread length/diameter. updates to the product monograph to address the procedural changes related to the device related changes and to add further device related precautions
- Therapeutic class
- Progestogen
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MIRENA | Not yet assigned | — |
Medicinal ingredients
- LEVONORGESTREL 52 MG per INS