Approval · Notice of Compliance 17192 · 2015
RAPAMUNE: Notice of Compliance 17192
Issued July 22, 2015
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
- 17192
- Date
- July 22, 2015
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Achange in the specification for the drug product involving the addition of a test for newly identified degradant and its corresponding test method relative response factor (rrf)
- Therapeutic class
- Immunosuppressive agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RAPAMUNE | Not yet assigned | — |
Medicinal ingredients
- SIROLIMUS 1 MG per TAB