This is a summary of the European public assessment report (EPAR) for Increlex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Increlex.
Therapeutic Indication
For the long\-term treatment of growth failure in children and adolescents with severe primary insulin\-like\-growth\-factor\-1 deficiency (primary IGFD). Severe primary IGFD is defined by: * height standard deviation score ? \-3\.0 and; * basal insulin\-like growth factor\-1 (IGF\-1\) levels below the 2\.5th percentile for age and gender and; * growth hormone (GH) sufficiency; * exclusion of secondary forms of IGF\-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti\-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post\-GHR signalling pathway, and IGF\-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF\-1 generation test.
Therapeutic Area (MeSH)
ATC Code
H01AC03
ATC Item
N/A
Pharmacotherapeutic Group
Pituitary and hypothalamic hormones and analogues
Active Substance (Summary)
INN / Common Names
EMA Name
Increlex
Medicine Name
Increlex
Aliases
N/ANo risk management plan link.
