Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Rhythm Pharmaceuticals Netherlands B.V., Radarweg 29, 1043NX Amsterdam, Netherlands
IMCIVREE 10 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to slightly opalescent, colourless to slightly coloured solution. |
1 ml of solution contains 10 mg of setmelanotide.
Each vial contains 10 mg setmelanotide in 1 ml of solution for injection.
Excipient(s) with known effect: 1 ml of solution contains 10 mg benzyl alcohol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Setmelanotide |
Setmelanotide is a selective MC4 receptor agonist. MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure. In genetic forms of obesity associated with insufficient activation of the MC4 receptor, setmelanotide is believed to re-establish MC4 receptor pathway activity to reduce hunger and promote weight loss through decreased caloric intake and increased energy expenditure. |
| List of Excipients |
|---|
|
N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-glycero-3-phosphoethanolamine sodium salt (mPEG-2000-DSPE) |
2R clear glass type I multidose vial with bromobutyl stopper and aluminium cap.
Packs of:
Not all pack sizes may be marketed.
Rhythm Pharmaceuticals Netherlands B.V., Radarweg 29, 1043NX Amsterdam, Netherlands
EU/1/21/1564/0001
EU/1/21/1564/0002
Date of first authorisation: 16 July 2021
| Drug | Countries | |
|---|---|---|
| IMCIVREE | Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland |
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