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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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|
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.
|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|