Approval · Notice of Compliance 11717 · 2010
RELISTOR: Notice of Compliance 11717
Issued September 17, 2010
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
- 11717
- Date
- September 17, 2010
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New dosage format and new manufacturing site
- Therapeutic class
- mcg-opioid receptor antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RELISTOR | Not yet assigned | — |
| RELISTOR (8MG/0.4ML PRE FILLED SYRINGE, SINGLE USE) | 02356481 | Approved |
| RELISTOR (12MG/0.6ML PRE FILLED SYRINGE, SINGLE USE) | 02356503 | Approved |
Medicinal ingredients
- METHYLNALTREXONE BROMIDE 20 MG per ML