Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Somatropin Biopartners   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Somatropina Biopartners (PT)
Auth. number : EU/1/13/849
Active substance : somatropin
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01A - Anterior pituitary lobe hormones
Chemical subgroup: H01AC - Somatropin and analogues
Chemical substance: H01AC01 - Somatropin
(See WHO ATC Index)
Indication: 2 mg, 4 mg and 7 mg: powder and solvent for prolonged-release suspension for injection:
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.

10 mg and 20 mg: powder and solvent for prolonged release suspension for injection:
Somatropin Biopartners is indicated in children and adolescents aged 2 to 18 years for long term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Marketing Authorisation Holder: BioPartners GmbH
Kaiserpassage 11, D-72764 Reutlingen, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
08/08/2013 Centralised - Authorisation EMEA/H/C/2196 (2013)5292 of 05/08/2013
13/12/2013 Centralised - Variation EMEA/H/C/2196/IA/2
Updated with Decision(2014)9994 of 15/12/2014
17/12/2014 Centralised - Yearly update (2014)9994 of 15/12/2014
16/11/2015 Centralised - Variation EMEA/H/C/2196/IA/8/G
Updated with Decision(2016) 6966 of 24/10/2016
26/10/2016 Centralised - Yearly update (2016) 6966 of 24/10/2016
03/03/2017 Centralised - Variation EMEA/H/C/2196/IAIN/10