Omnitrope

somatropin

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Omnitrope?

Omnitrope is a medicine containing the active substance somatropin. It is available as a powder and solvent, which are made up into a solution for injection (1.3 or 5 mg/ml), or as a ready-to-use solution in a cartridge (3.3 or 6.7 mg/ml).

Omnitrope is a ‘biosimilar medicine'. This means that Omnitrope is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine’). The reference medicine for Omnitrope is Genotropin.

What is Omnitrope used for?

Omnitrope is used to treat children:

  • who have trouble with their growth because they do not have enough growth hormone (GH);
  • when they are short because they have chronic renal insufficiency (malfunctioning kidneys) or a genetic disorder called Turner syndrome;
  • when they are short, because they were born small for their gestational age, and have not caught up by the age of four years or later;
  • when they have a genetic condition called Prader-Willi syndrome. Omnitrope is given to improve their growth and their body composition (relationship of fat and muscle mass). The diagnosis must be confirmed by appropriate genetic testing.

Omnitrope is also used to treat adult patients with pronounced GH deficiency as replacement therapy.

The medicine can only be obtained with a prescription.

How is Omnitrope used?

Omnitrope treatment should be supervised by a doctor experienced in the management of patients with growth disorders. Omnitrope is given by subcutaneous injection (under the skin), once a day at bedtime. The patient or caregiver can inject Omnitrope themselves, after training 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, depending on 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.

How does Omnitrope work?

GH is a substance secreted by the pituitary gland (a gland located at the base of the brain). It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates. The active substance in Omnitrope, somatropin, is identical to the human GH. It is produced by a method known as ‘recombinant DNA technology’: the hormone is made by a bacterium which has received a gene (DNA) that makes it able to produce it. Omnitrope replaces the natural hormone.

How has Omnitrope been studied?

Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin. Omnitrope was compared to Genotropin in 89 children with a lack of GH and who had not been treated before. The study lasted nine months, and measured the height at the beginning and the end of the study, and the speed of growth during the study. To study the safety of Omnitrope, another 51 children have also received the medicine for up to a year.

What benefit has Omnitrope shown during the studies?

After nine months, treatment with Omnitrope and Genotropin gave similar increases in height and speed of growth (equivalent to an increase of 10.7 cm per year with both medicines). The effectiveness of Omnitrope has been shown to be equivalent to that of Genotropin.

What is the risk associated with Omnitrope?

The side effects seen with Omnitrope were similar in type and severity to those seen with the reference medicine Genotropin. The most common side effects (seen in between 1 and 10 patients in 100) are, in children, transient local skin reactions at the site of injection, and in adults, mild oedema (accumulation of fluid), paraesthesia (numbness or tingling), joint and muscle pain (especially in the hip or knee) and stiffness of the limbs. In addition, as with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope). However these have no growth-inhibiting effects. For the full list of all side effects reported with Omnitrope, see the package leaflet.

Omnitrope should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the ready-to-use solution and the solvent for Omnitrope 5 mg/ml contain benzyl alcohol). Omnitrope should not be used when the patient suffers from an active tumour or an acute life-threatening illness. For the full list of restrictions, see the package peaflet.

Somatropin may interfere with the body’s use of insulin. Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be adjusted or started.

Why has Omnitrope been approved?

The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin. Therefore, the CHMP's view was that, as for Genotropin, the benefit outweighs the identified risk.

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

The measures taken to ensure the safe use of Omnitrope are linked to the reasons why the medicine is used. The company that makes Omnitrope will study in more detail potential long-term side effects of the medicine, such as the possible risk of developing diabetes or re-occurrence of some types of cancer when receiving long-term somatropin treatment, and implications of the development of antibodies on effectiveness.

Other information about Omnitrope

The European Commission granted a marketing authorisation valid throughout the EU for Omnitrope to Sandoz GmbH on 12 April 2006.

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

This EPAR was last updated on 12/07/2016 .

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

Revision12
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

18/02/2015  Omnitrope -EMEA/H/C/000607 -IB/0040

Name Language First published Last updated
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13
Omnitrope : EPAR - Product Information SV = svenska 2008-04-02 2015-05-13

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 SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 2008-01-21 2015-11-04
Omnitrope : EPAR - All Authorised presentations SV = svenska 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 SV = svenska 2006-04-25  
Omnitrope : EPAR - Scientific Discussion SV = svenska 2006-04-25  

Authorised

This medicine is approved for use in the European Union

More information on Omnitrope