Table of contents
This marketing authorisation for Somatropin Biopartners has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Somatropin Biopartners : EPAR - Summary for the public (PDF/544.61 KB)
First published: 09/09/2013
Last updated: 01/12/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
13/03/2017 Somatropin Biopartners - EMEA/H/C/002196 - IAIN/0010
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Somatropin and somatropin agonists
Pituitary and hypothalamic hormones and analogues
Somatropin Biopartners is indicated 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 excluding 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-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.