Approval · Notice of Compliance 22999 · 2019
RELISTOR: Notice of Compliance 22999
Issued December 9, 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
- 22999
- Date
- December 9, 2019
- 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
- Changes to the manufacturing process and controls for methylnaltrexone bromide drug substance, which is manufactured by specgx llc (a subsidiary of mallinckrodt plc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RELISTOR | Not yet assigned | — |
Medicinal ingredients
- METHYLNALTREXONE BROMIDE 20 MG per ML