Approval · Notice of Compliance 21839 · 2019
RENVELA: Notice of Compliance 21839
Issued February 7, 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.
- Notice number
- 21839
- Date
- February 7, 2019
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add a new dosage form as powder for oral suspension and to add pediatric indication
Products in this notice
Medicinal ingredients
- SEVELAMER CARBONATE 800 MG per TAB
- SEVELAMER CARBONATE 0.8 G per PCK
- SEVELAMER CARBONATE 2.4 G per PCK