Approval · Notice of Compliance 38313 · 2026
IMCIVREE: Notice of Compliance 38313
Issued September 18, 2026
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
- 38313
- Date
- September 18, 2026
- Company
- Rhythm Pharmaceuticals, IncBoston, Massachusetts, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Addition of new indication: Weight management in adult and pediatric patients 4 years of age and older with acquired hypothalamic obesity (aHO). Update to the Product Monograph with new safety and efficacy information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IMCIVREE | Not yet assigned | — |
Medicinal ingredients
- SETMELANOTIDE ACETATE 10 MG per ML