Approval · Notice of Compliance 22387 · 2019
VITRAKVI: Notice of Compliance 22387
Issued July 10, 2019
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
- 22387
- Date
- July 10, 2019
- Company
- Bayer Inc.Elkhart, Indiana, United States
- 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
- LAROTRECTINIB 25 MG per CAP
- LAROTRECTINIB 100 MG per CAP
- LAROTRECTINIB 20 MG per ML