Omnitrope

RSS

somatropin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Omnitrope. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Omnitrope.

For practical information about using Omnitrope, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/06/2018

Authorisation details

Product details
Name
Omnitrope
Agency product number
EMEA/H/C/000607
Active substance
somatropin
International non-proprietary name (INN) or common name
somatropin
Therapeutic area (MeSH)
  • Turner Syndrome
  • Prader-Willi Syndrome
  • Dwarfism, Pituitary
Anatomical therapeutic chemical (ATC) code
H01AC01
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Sandoz GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
12/04/2006
Contact address
Biochemiestrasse 10
AT-6250 Kundl
Austria

Product information

27/02/2018 Omnitrope - EMEA/H/C/000607 - PSUSA/00002772/201703

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Therapeutic 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.
  • Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Adults

  • Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.

Assessment history

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