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somatropin (Somatropin Biopartners®)


Reference No. 2256

Publication date:
27/02/2014


Appraisal information

somatropin (Somatropin Biopartners®) 2 mg powder and solvent for prolonged-release suspension for injection
somatropin (Somatropin Biopartners®) 4 mg powder and solvent for prolonged-release suspension for injection
somatropin (Somatropin Biopartners®) 7 mg powder and solvent for prolonged-release suspension for injection
somatropin (Somatropin Biopartners®) 10 mg powder and solvent for prolonged-release suspension for injection
somatropin (Somatropin Biopartners®) 20 mg powder and solvent for prolonged-release suspension for injection


Company: Biopartners GmbH
BNF category: Endocrine system
NMG meeting date: Not scheduled
AWMSG meeting date: Not scheduled
   
   
Submission Type: Nonsubmission
Status: Not endorsed
Advice No: Not available
Ratification by Welsh Government: 26/02/2014

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ratification by
Welsh Government

AWMSG 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.
Statement of Advice (SOA)
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