Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Ngenla 24 mg solution for injection in pre-filled pen.
Ngenla 60 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is a clear and colourless to slightly light yellow solution with a pH of 6.6. |
Ngenla 24 mg solution for injection in pre-filled pen:
One mL of solution contains 20 mg of somatrogon*.
Each pre-filled pen contains 24 mg somatrogon in 1.2 mL solution.
Each pre-filled pen delivers doses from 0.2 mg to 12 mg in a single injection in 0.2 mg increments.
Ngenla 60 mg solution for injection in pre-filled pen:
One mL of solution contains 50 mg of somatrogon.
Each pre-filled pen contains 60 mg somatrogon in 1.2 mL solution.
Each pre-filled pen delivers doses from 0.5 mg to 30 mg in a single injection in 0.5 mg increments.
* Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Somatrogon |
Somatrogon is a glycoprotein comprised of the amino acid sequence of hGH with one copy of the of C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. |
| List of Excipients |
|---|
|
Trisodium citrate dihydrate |
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured lilac.
Pack size of 1 pre-filled pen.
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured blue.
Pack size of 1 pre-filled pen.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/21/1617/001
EU/1/21/1617/002
| Drug | Countries | |
|---|---|---|
| NGENLA | Canada, Estonia, Croatia, Italy, Japan, Poland, Romania, Turkey |
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