Approval · Notice of Compliance 7380 · 2005
PROVERA: Notice of Compliance 7380
Issued September 16, 2005
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
- 7380
- Date
- September 16, 2005
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph: to include recent study findings presenting the potential oeefect on bone mineral density in adult women and adolescents
- Therapeutic class
- Progestin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROVERA | Not yet assigned | — |
| PROVERA-PAK | Not yet assigned | — |
Medicinal ingredients
- MEDROXYPROGESTERONE ACETATE 2.5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 10 MG per TAB
- MEDROXYPROGESTERONE ACETATE 100 MG per TAB