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Trade names | Ngenla |
Other names | MOD-4023, somatrogon-ghla |
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Routes of administration | Subcutaneous injection |
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Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency. [1] [5] [7] Somatrogon is a glycosylated protein constructed from human growth hormone and a small part of human chorionic gonadotropin which is appended to both the N-terminal and C-terminal. [7]
The most common side effects include reactions at the site of injection, headache, and fever. [6]
Somatrogon was approved for medical use in Australia in November 2021, [1] in the European Union in February 2022, [6] and in the United States in June 2023. [8]
On 16 December 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ngenla, intended for the treatment of growth hormone deficiency in children and adolescents from three years of age. [9] The applicant for this medicinal product is Pfizer Europe MA EEIG. [9] Somatrogon was approved for medical use in the European Union in February 2022. [6] [10]
Somatrogon is the international nonproprietary name. [11]
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