Approval · Notice of Compliance 13968 · 2012
TORISEL: Notice of Compliance 13968
Issued December 28, 2012
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
- 13968
- Date
- December 28, 2012
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the Product Monograph; effectiveness in pediatric population not extablished; updates to the Warnings and Precautions, Dosage and Aministration and Action and CLinical Pharmacology
- Therapeutic class
- Mtor kinase inhibitor - antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TORISEL | Not yet assigned | — |
Medicinal ingredients
- TEMSIROLIMUS 25 MG per ML