Approval · Notice of Compliance 21138 · 2018
RELISTOR: Notice of Compliance 21138
Issued July 25, 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.
- Notice number
- 21138
- Date
- July 25, 2018
- Company
- Salix Pharmaceuticals IncBridgewater, New Jersey, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To expand the patient population to include those with severe hepatic impairment and to provide more information regarding dosing for patients with renal impairment.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RELISTOR | Not yet assigned | — |
Medicinal ingredients
- METHYLNALTREXONE BROMIDE 20 MG per ML