Approval · Notice of Compliance 30374 · 2022
TABRECTA: Notice of Compliance 30374
Issued May 26, 2022
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
- 30374
- Date
- May 26, 2022
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- CAPMATINIB HYDROCHLORIDE 150 MG per TAB
- CAPMATINIB HYDROCHLORIDE 200 MG per TAB