Approval · Notice of Compliance 4271 · 2004
GLEEVEC: Notice of Compliance 4271
Issued June 2, 2004
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 4271
- Date
- June 2, 2004
- 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
- New dosage form: tablets
- Therapeutic class
- Protein kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- IMATINIB MESYLATE 100 MG per TAB
- IMATINIB MESYLATE 400 MG per TAB