Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France
INCRELEX 10 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Aqueous, clear and colourless solution. |
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 |
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.
Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France
EU/1/07/402/001
Date of first authorisation: 03 August 2007
Date of latest renewal: 03 August 2017
| Drug | Countries | |
|---|---|---|
| INCRELEX | Austria, Cyprus, Ecuador, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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