Omnitrope

somatropin

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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.

What is Omnitrope and what is it used for?

Omnitrope is a medicine used to treat children who:

  • do not grow normally because they do not have enough growth hormone;
  • are short because they have long-term kidney disease or a genetic disorder called Turner syndrome;
  • are short and were born small for their gestational age, and have not caught up by the age of 4 years or later;
  • have a genetic condition called Prader-Willi syndrome. Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass). The diagnosis must be confirmed by genetic testing.

Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency. The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.

Omnitrope contains the active substance somatropin and is a ‘biosimilar’ medicine. This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine’) that is already authorised in the EU.

How is Omnitrope used?

Omnitrope can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with growth disorders.

The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge. It is given by injection under the skin, once a day. The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse. The Omnitrope cartridges should only be used with the special Omnitrope injection device. The doctor calculates the dose for each patient individually according to the body weight and the condition being treated. The dose may need to be adjusted over time, depending on change in body weight and response to treatment.

For further information, see the package leaflet.

How does Omnitrope work?

Growth hormone is released by the pituitary gland (a gland at the base of the brain). It is important for growth during childhood and adolescence, and it also affects how the body handles proteins, fat and carbohydrates. The active substance in Omnitrope, somatropin, is identical to the human growth hormone, which it replaces. Somatropin is produced by a method known as ‘recombinant DNA technology’: the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.

What benefits of Omnitrope have been shown in studies?

Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin. Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before. Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth. Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.

What are the risks associated with Omnitrope?

In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100). These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000). As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope). Howeve,r these antibodies do not have an effect on how well Omnitrope works. For the full list of side effects of Omnitrope, see the package leaflet.

Omnitrope must not be used if the patient has an active tumour or an acute life-threatening illness. It must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing). For the full list of restrictions, see the package leaflet.

Why is Omnitrope approved?

The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin. Therefore, the Agency’s view was that, as for Genotropin, the benefit outweighs the identified risk and it recommended that Omnitrope be given marketing authorisation.

What measures are being taken to ensure the safe use of Omnitrope?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Omnitrope have been included in the summary of product characteristics and the package leaflet.

Other information about Omnitrope

The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.

For more information about treatment with Omnitrope, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Omnitrope : EPAR - Summary for the public BG = bălgarski 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public ES = español 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public CS = čeština 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public DA = dansk 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public DE = Deutsch 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public ET = eesti keel 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public EL = elliniká 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public EN = English 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public FR = français 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public IT = italiano 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public LV = latviešu valoda 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public LT = lietuvių kalba 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public HU = magyar 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public MT = Malti 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public NL = Nederlands 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public PL = polski 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public PT = português 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public RO = română 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public SK = slovenčina 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public SL = slovenščina 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public FI = suomi 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public SV = svenska 2008-04-23 2018-03-06
Omnitrope : EPAR - Summary for the public HR = Hrvatski 2008-04-23 2018-03-06

This EPAR was last updated on 19/06/2018 .

Authorisation details

Product details

Product details for Omnitrope
NameOmnitrope
Agency product numberEMEA/H/C/000607
Active substance

somatropin

International non-proprietary name (INN) or common name

somatropin

Therapeutic area Prader-Willi SyndromeDwarfism, PituitaryTurner Syndrome
Anatomical therapeutic chemical (ATC) code H01AC01
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Omnitrope
Marketing-authorisation holder

Sandoz GmbH

Revision15
Date of issue of marketing authorisation valid throughout the European Union12/04/2006

Contact address:

Sandoz GmbH
Biochemiestrasse 10
AT-6250 Kundl
Austria

Product information

Product information

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

Name Language First published Last updated
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06
Omnitrope : EPAR - Product Information HR = Hrvatski 2008-04-02 2018-03-06

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.


Name Language First published Last updated
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations HR = Hrvatski 2008-01-21 2015-11-04

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Omnitrope : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-04-25  
Omnitrope : EPAR - Scientific Discussion HR = Hrvatski 2006-04-25  

Authorised

This medicine is approved for use in the European Union

More information on Omnitrope

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