🇪🇺 Omnitrope in European Union

EMA authorised Omnitrope on 12 April 2006

Marketing authorisation

Application: EMEA/H/C/000607
Marketing authorisation holder: Sandoz GmbH
Local brand name: Omnitrope
Indication: Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (GH). Growth disturbance associated with Turner syndrome. Growth disturbance associated with chronic renal insufficiency. Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later. Pr
Pathway: biosimilar
Status: approved

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

Is Omnitrope approved in European Union?

Yes. EMA authorised it on 12 April 2006.

Who is the marketing authorisation holder for Omnitrope in European Union?

Sandoz GmbH holds the EU marketing authorisation.