🇪🇺 Saizen® in European Union

EMA authorised Saizen® on 24 April 2006

Marketing authorisations

Application: EMEA/H/C/000602
Marketing authorisation holder: BioPartners GmbH
Local brand name: Valtropin
Indication: Paediatric poulation Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as pat
Pathway: biosimilar
Status: withdrawn

Application: EMEA/H/C/002196
Marketing authorisation holder: BioPartners GmbH
Local brand name: Somatropin Biopartners
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 dy
Status: withdrawn

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Saizen® approved in European Union?

Yes. EMA authorised it on 24 April 2006; EMA authorised it on 5 August 2013.

Who is the marketing authorisation holder for Saizen® in European Union?

BioPartners GmbH holds the EU marketing authorisation.