Approval · Notice of Compliance 9290 · 2008
GLEEVEC: Notice of Compliance 9290
Issued January 10, 2008
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
- 9290
- Date
- January 10, 2008
- 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 indications: for the treatment of: adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor gene rearrangements; adult patients with aggressive sub-types of systemic mastocytosis (asm and sm-ahnmd) without the d816v c-kit mutation. if c-kit mutational status in patients with asm or sm-ahnmd is not known or unavailable, treatment with gleevec may be considered if there is no satisfactory response to other therapies; adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukemia (cel) with fip1l1-pdgfr rearrangement; and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)
- Therapeutic class
- Protein kinase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GLEEVEC | Not yet assigned | — |
Medicinal ingredients
- IMATINIB MESYLATE 100 MG per CAP
- IMATINIB MESYLATE 100 MG per TAB
- IMATINIB MESYLATE 400 MG per TAB