Approval · Notice of Compliance 9020 · 2007
GLEEVEC: Notice of Compliance 9020
Issued September 12, 2007
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
- 9020
- Date
- September 12, 2007
- 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
- Revision to product monograph sections warnings and precautions, adverse reactions, dosage and administration, clinical trials, action and clinical pharmacology; post approval commitment #1 & 2 (newly diagnosed cml) and post approval commitment # 18 (2nd line cml)
- Therapeutic class
- Protein kinase inhibitor
- With conditions
- Yes (NOC/c)
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
- IMATINIB MESYLATE 100 MG per CAP