Approval · Notice of Compliance 408 · 2003
PREMPLUS: Notice of Compliance 408
Issued April 3, 2003
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
- 408
- Date
- April 3, 2003
- Company
- Wyeth CanadaSt. Laurent, 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 |
|---|---|---|
| PREMPLUS | 02242878 | Cancelled Post Market |
| PREMPLUS | 02242879 | Cancelled Post Market |
| PREMPLUS CYCLE | 02242880 | Cancelled Pre Market |
Medicinal ingredients
- CONJUGATED ESTROGENS 0.625 MG per TAB
- MEDROXYPROGESTERONE ACETATE 2.5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 5 MG per TAB
- MEDROXYPROGESTERONE ACETATE 10 MG per TAB