Approval · Notice of Compliance 34263 · 2024
FOLOTYN: Notice of Compliance 34263
Issued October 22, 2024
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
- 34263
- Date
- October 22, 2024
- Company
- Servier Canada Inc.Laval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to the Notice of Compliance with Conditions - Qualifying Notice
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOLOTYN | Not yet assigned | — |
Medicinal ingredients
- PRALATREXATE 20 MG per ML
- PRALATREXATE 40 MG per 2ML