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Somatropin Biopartners

Active Substance: somatropin
Common Name: somatropin
ATC Code: H01AC01
Marketing Authorisation Holder: BioPartners GmbH
Active Substance: somatropin
Status: Withdrawn
Authorisation Date: 2013-08-05
Therapeutic Area: Growth
Pharmacotherapeutic Group: Pituitary and hypothalamic hormones and analogues, somatropin and agonists

Therapeutic Indication

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.

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.

Source: European Medicines Agency

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