Approval · Notice of Compliance 10811 · 2009
TASIGNA: Notice of Compliance 10811
Issued November 26, 2009
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
- 10811
- Date
- November 26, 2009
- 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
- Commitment 3 as per Letter of Undertaking: Clinical study report (A2116) for patients with hepatic impairment. Also provided clinical study report A2103 (Pgp interactions) and Pre-Clinical study 901168 (oral pre and postnatal study in rat)
- 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