Approval · Notice of Compliance 12495 · 2011
SPRYCEL: Notice of Compliance 12495
Issued July 19, 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
- 12495
- Date
- July 19, 2011
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: For the Treatment of adults with newly diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML) in Chronic Phase
- Therapeutic class
- Protein-tyrosine Kinase Inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPRYCEL | Not yet assigned | — |