Approval · Notice of Compliance 12908 · 2012
GLEEVEC: Notice of Compliance 12908
Issued January 4, 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
- 12908
- Date
- January 4, 2012
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Drug-Drug Interactions, Warnings and Precautions, Adverse Reactions and References sections of the Product Monograph regarding tumour lysis syndrome and interactions with acetaminophen.
- Therapeutic class
- Protein Kinase Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GLEEVEC | Not yet assigned | — |
Medicinal ingredients
- IMATINIB MESYLATE 100 MG per TAB
- IMATINIB MESYLATE 400 MG per TAB