NUTROPINAQ Solution for injection Ref.[27676] Active ingredients: Somatropin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

Product name and form

NutropinAq 10 mg/2 ml (30 IU) solution for injection.

Pharmaceutical Form

Solution for injection.

Clear and colourless solution.

Qualitative and quantitative composition

One ml contains 5 mg of somatropin*.

One cartridge contains 10 mg (30 IU) of somatropin.

* Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Somatropin

Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate. In adults, as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilization of body fat.

List of Excipients

Sodium chloride
Liquified phenol
Polysorbate 20
Sodium citrate dihydrate
Citric acid, anhydrous
Water for injections

Pack sizes and marketing

2 ml of solution in a cartridge (Type I glass) closed with a stopper (butyl rubber) and a seal (rubber).

Pack sizes of 1, 3 and 6 cartridges.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/00/164/003
EU/1/00/164/004
EU/1/00/164/005

Date of first authorisation: 16 February 2001
Date of latest renewal: 16 February 2006

Drugs

Drug Countries
NUTROPINAQ Australia, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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