Approval · Notice of Compliance 9142 · 2007
RENAGEL: Notice of Compliance 9142
Issued October 30, 2007
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
- 9142
- Date
- October 30, 2007
- Company
- Genzyme Canada Inc
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extend indication: renagel is indicated for: the control of hyperphosphatemia in patients with end-stage renal disease (esrd) undergoing dialysis and other revision to the product monograph
- Therapeutic class
- Phosphate binder
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RENAGEL | Not yet assigned | — |
Medicinal ingredients
- SEVELAMER HYDROCHLORIDE 800 MG per TAB