Approval · Notice of Compliance 11758 · 2010
PREMELLE: Notice of Compliance 11758
Issued September 29, 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
- 11758
- Date
- September 29, 2010
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Estrogenic hormones / Progestin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREMELLE | 02243226 | — |
| PREMELLE | 02243227 | — |
Medicinal ingredients
- CONJUGATED ESTROGENS 0.625 MG per TAB
- MEDROXYPROGESTERONE ACETATE 2.5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 5 MG per TAB