INCRELEX Solution for injection Ref.[9554] Active ingredients: Mecasermin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France

Product name and form

INCRELEX 10 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Aqueous, clear and colourless solution.

Qualitative and quantitative composition

Each ml contains 10 mg of mecasermin*.

Each vial of 4 ml contains 40 mg of mecasermin*.

* Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.

Excipient with known effect: One ml contains 9 mg of benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mecasermin

Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth. Mecasermin is indicated for the long-term treatment of growth failure in patients with confirmed severe primary insulin-like growth factor-1 deficiency (Primary IGFD).

List of Excipients

Benzyl alcohol
Sodium chloride
Polysorbate 20
Glacial acetic acid
Sodium acetate
Water for injections

Pack sizes and marketing

5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).

Each vial contains 4 ml of solution.

Pack size of 1 vial.

Marketing authorization holder

Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France

Marketing authorization dates and numbers

EU/1/07/402/001

Date of first authorisation: 03 August 2007
Date of latest renewal: 03 August 2017

Drugs

Drug Countries
INCRELEX Austria, Cyprus, Ecuador, Estonia, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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