Approval · Notice of Compliance 412 · 2003
PREMELLE: Notice of Compliance 412
Issued April 2, 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
- 412
- Date
- April 2, 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 |
|---|---|---|
| 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