Approval · Notice of Compliance 8074 · 2006
PREMPLUS: Notice of Compliance 8074
Issued June 26, 2006
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
- 8074
- Date
- June 26, 2006
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety updates to the product monograph including hrt class labelling text and modifications to the indications
- Therapeutic class
- Estrogenic hormones / progestin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREMPLUS | Not yet assigned | — |
| PREMPLUS CYCLE | 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