Somatropin Biopartners

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somatropin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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
Name
Somatropin Biopartners
Agency product number
EMEA/H/C/002196
Active substance
somatropin
International non-proprietary name (INN) or common name
somatropin
Therapeutic area (MeSH)
Growth
Anatomical therapeutic chemical (ATC) code
H01AC01
Publication details
Marketing-authorisation holder
BioPartners GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
04/08/2013
Contact address
Kaiserpassage 11
D-72764 Reutlingen
Germany

Product information

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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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