Export

Somatropin
The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
Section:
18. Medicines for endocrine disorders
Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected Rejected
ATC codes: H01AC01
EMLc
Indication
Hypoglycaemia without associated diabetes ICD11 code: 5A41
INN
Somatropin
Medicine type
Biological agent
List type
Core
Formulations
Parenteral > General injections > SC: 5 mg in cartridge powder for injection ; 5 mg per mL in 2 mL cartridge
EML status history
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Children (1 month - 12 years)
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Wikipedia
Somatropin
DrugBank
Somatropin (Somatotropin)
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend the inclusion of somatropin on the complementary list of the EMLc for the management of hypoglycaemia secondary to growth hormone deficiency in neonates, infants and young children. The Committee acknowledged that the management of hypoglycaemia, of any aetiology, in neonates and infants is critical to prevent permanent neurological sequelae. However, the Committee considered that comparative evidence for somatropin versus other medicines for management of hypoglycaemia currently included on the Model Lists (e.g. diazoxide, glucagon, glucose) and information regarding the comparative costs and cost-effectiveness would be necessary to inform any future consideration for somatropin in this indication.