Approval · Notice of Compliance 21837 · 2019
IDHIFA: Notice of Compliance 21837
Issued February 6, 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
- 21837
- Date
- February 6, 2019
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- ENASIDENIB MESYLATE 50 MG per TAB
- ENASIDENIB MESYLATE 100 MG per TAB