Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen.
Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear to slightly opalescent, colourless to slightly yellow liquid, essentially free from visible particles. |
Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen: One mL of solution cotains 3.3 mg of somapacitan*. Each pre-filled pen contains 5 mg of somapacitan in 1.5 mL solution.
Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen: One mL of solution contains 6.7 mg of somapacitan*. Each pre-filled pen contains 10 mg of somapacitan in 1.5 mL solution.
* Produced by recombinant DNA technology in Escherichia coli followed by attachment of an albumin binding moiety.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Somapacitan |
Somapacitan is a long-acting recombinant human growth hormone derivative. The mechanism of action of somapacitan is either directly via the GH-receptor and/or indirectly via IGF-I produced in tissues throughout the body, but predominantly by the liver. When growth hormone deficiency is treated with somapacitan a normalisation of body composition (i.e., decreased body fat mass, increased lean body mass) and of metabolic action is achieved. |
| List of Excipients |
|---|
|
Histidine |
The pre-filled pen consists of 1.5 mL solution in a glass cartridge (Type I colourless glass) with a plunger made of chlorobutyl rubber and a stopper made of bromobutyl/isoprene rubber sealed with an aluminium cap. The cartridge is contained in a multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene and in addition two metal springs. The cartridge is permanently sealed in a pen-injector.
Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen: A colour-coded pre-filled pen with the dose button on the pen-injector coloured teal.
Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen: A colour-coded pre-filled pen with the dose button on the pen-injector coloured yellow.
Pack sizes of 1 pre-filled pen and multipack of 5 (5 packs of 1) pre-filled pens. Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
EU/1/20/1501/001
EU/1/20/1501/002
EU/1/20/1501/003
EU/1/20/1501/004
Date of first authorisation: 31 March 2021
| Drug | Countries | |
|---|---|---|
| SOGROYA | Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania |
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