Approval · Notice of Compliance 411 · 2003
PREMPLUS TABLETS: Notice of Compliance 411
Issued November 25, 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
- 411
- Date
- November 25, 2003
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product monograph update resulting from the women's health initiative (whi) study
- Therapeutic class
- Estrogenic hormones, progestin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREMPLUS TABLETS | Not yet assigned | — |
| PREMPLUS CYCLE TABLETS | Not yet assigned | — |
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