Somatropin Biopartners
somatropin
Table of contents
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.
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 |
05/08/2013
|
| Contact address |
Kaiserpassage 11
D-72764 Reutlingen Germany |
Product information
13/03/2017 Somatropin Biopartners - EMEA/H/C/002196 - IAIN/0010
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
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.