Approval · Notice of Compliance 25862 · 2021
VITRAKVI: Notice of Compliance 25862
Issued May 13, 2021
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
- 25862
- Date
- May 13, 2021
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VITRAKVI | Not yet assigned | — |
Medicinal ingredients
- LAROTRECTINIB SULFATE 25 MG per CAP
- LAROTRECTINIB SULFATE 100 MG per CAP
- LAROTRECTINIB SULFATE 20 MG per ML