Approval · Notice of Compliance 21458 · 2018
FOLOTYN: Notice of Compliance 21458
Issued October 26, 2018
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
- 21458
- Date
- October 26, 2018
- Company
- Servier Canada Inc.Laval, 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
- PRALATREXATE 20 MG per ML
- PRALATREXATE 40 MG per 2ML