https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=6CFD3697-6990-435C-A774-C37B60CB4777

許可證字號：衛署菌疫輸字第000845號 有效日期：20250513

製造廠名稱: 1. Vetter Pharma-Fertigung GmbH & Co. KG 2. Pfizer Manufacturing Belgium N.V. 製造廠登記: 製造廠核定編號: 116-0862-4 / 114-0303, 製造廠品管: PIC/S GMP

{"產品驗證": "https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=6CFD3697-6990-435C-A774-C37B60CB4777"}

Clinical Trial 1.Horikawa R, Tanaka T, Hasegawa Y, et al. Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study. Horm Res Paediatr. 2022;95(3):275-285. doi:10.1159/000524600 2.Deal CL, Steelman J, Vlachopapadopoulou E, et al. Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study. J Clin Endocrinol Metab. 2022;107(7):e2717-e2728. doi:10.1210/clinem/dgac220 3.Zadik Z, Zelinska N, Iotova V, et al. An open-label extension of a phase 2 dose-finding study of once-weekly somatrogon vs. once-daily Genotropin in children with short stature due to growth hormone deficiency: results following 5 years of treatment. J Pediatr Endocrinol Metab. 2023;36(3):261-269. Published 2023 Feb 3. doi:10.1515/jpem-2022-0359 Real-World Study 1.Maghnie M, Ranke MB, Geffner ME, et al. Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort. J Clin Endocrinol Metab. 2022;107(12):3287-3301. doi:10.1210/clinem/dgac517 2.Johannsson G, Touraine P, Feldt-Rasmussen U, et al. Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients. J Clin Endocrinol Metab. 2022;107(7):1906-1919. doi:10.1210/clinem/dgac199