Approval · Notice of Compliance 12564 · 2011
TASIGNA: Notice of Compliance 12564
Issued August 18, 2011
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
- 12564
- Date
- August 18, 2011
- 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
- Fulfillment of Commitment #1 as per the Letter of Undertaking dated July 10, 2008 for the treatment of accelerated phase Philadelphia chromosome positive myelogenous leukemia (CML) in adult patients resistant to or tolerant of at least one prior therapy including imatinib; and other revisions to the Product Monograph. Fulfillment of Commitments as per the Letters of Undertaking dated July 10, 2008 and June 21, 2010 for the treatment of chronic phase Phiadelphia chromosome positive chronic myelogenous leukemia (CML) in patients resistant to or intolerant of at least one prior therapy including imatinib.
- Therapeutic class
- Protein-tyrosine Kinase Inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TASIGNA | Not yet assigned | — |
Medicinal ingredients
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 MG per CAP
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 MG per CAP