IMCIVREE Solution for injection Ref.[27947] Active ingredients: Setmelanotide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Rhythm Pharmaceuticals Netherlands B.V., Herengracht 280, 1016BX Amsterdam, Netherlands

Product name and form

IMCIVREE 10 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to slightly coloured solution.

Qualitative and quantitative composition

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)
Carmellose sodium
Mannitol
Phenol
Benzyl alcohol
Disodium edetate
Water for injections

Pack sizes and marketing

2R clear glass type I multidose vial with bromobutyl stopper and aluminium cap.

Pack size: 1 multidose vial.

Marketing authorization holder

Rhythm Pharmaceuticals Netherlands B.V., Herengracht 280, 1016BX Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/21/1564/0001

Date of first authorisation: 16 July 2021

Drugs

Drug Countries
IMCIVREE Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland
 
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