Following non-submission
AWMSG advice |
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Status: Not endorsed (Statement of Advice) | ||
In the absence of a submission from the holder of the marketing authorisation, somatropin (Somatropin Biopartners®) cannot be endorsed for use within NHS Wales for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD). • Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. • Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-1 (IGF-1) concentrations (< -2 standard deviation score [SDS]), who may be considered for one test. The cut-off point of the dynamic test should be strict. |
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Medicine details |
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Medicine name | somatropin (Somatropin Biopartners®) | |
Formulation | 2 mg powder and solvent for prolonged-release suspension for injection, 4 mg powder and solvent for prolonged-release suspension for injection, 7 mg powder and solvent for prolonged-release suspension for injection, 10 mg powder and solvent for prolonged-release suspension for injection, 20 mg powder and solvent for prolonged-release suspension for injection | |
Reference number | 2256 | |
Indication | For the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD). • Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. • Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-1 (IGF-1) concentrations (< -2 standard deviation score [SDS]), who may be considered for one test. The cut-off point of the dynamic test should be strict. |
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Company | Biopartners GmbH | |
BNF chapter | Endocrine system | |
Submission type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Ratification by Welsh Government | 26/02/2014 | |
Date of issue | 27/02/2014 |