Somatropin Biopartners



This medicine is now withdrawn from use in the European Union.


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.

This EPAR was last updated on 01/12/2017

Authorisation details

Product details
Somatropin Biopartners
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
BioPartners GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Kaiserpassage 11
D-72764 Reutlingen

Product information

13/03/2017 Somatropin Biopartners - EMEA/H/C/002196 - IAIN/0010

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Somatropin and somatropin agonists
  • Pituitary and hypothalamic hormones and analogues

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.

Assessment history

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