Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Omnitrope   
Auth. number : EU/1/06/332
INN : Somatropin
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01A - Anterior pituitary lobe hormones
Chemical subgroup: H01AC - Somatropin and analogues
Chemical substance: H01AC01 - Somatropin
(See WHO ATC Index)
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 deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 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 IGF-I concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.
All other patients will require IGF-I assay and one growth hormone stimulation test.
Marketing Authorisation Holder: Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/04/2006 Centralised - Authorisation EMEA/H/C/607 (2006)1668 of 12/04/2006
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/IB/5
24/04/2007 Centralised - Variation EMEA/H/C/607/X/1 (2007)1859 of 20/04/2007
18/05/2007 Centralised - Variation EMEA/H/C/607/II/3 (2007)2190 of 15/05/2007
10/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/II/6
21/09/2007 Centralised - Variation EMEA/H/C/607/X/2 (2007)4405 of 19/09/2007
19/10/2007 Corrigendum EMEA/H/C/607/X/2 (2007)4405 corr of 15/10/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/II/7
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/I/8
20/03/2008 Centralised - Variation EMEA/H/C/607/II/9 (2008)1775 of 18/03/2008
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/II/11
13/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/IB/13
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/II/12
01/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/II/16
30/11/2010 Centralised - Variation EMEA/H/C/607/IA/19/G:
Updated with Decision(2011)1474 of 28/02/2011
30/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/607/IA/20
02/03/2011 Centralised - Renewal EMEA/H/C/607/R/18 (2011)1474 of 28/02/2011
21/06/2011 Centralised - Variation EMEA/H/C/607/X/17 (2011)4400 of 16/06/2011
04/10/2011 Centralised - Variation EMEA/H/C/607/IB/25/G
Updated with Decision(2012)1505 of 02/03/2012
06/03/2012 Referral EMEA/H/C/607/A-20/21 (2012)1505 of 02/03/2012
17/07/2013 Centralised - Variation EMEA/H/C/607/IA/31/G
Updated with Decision(2014)5244 of 18/07/2014
19/09/2013 Centralised - Variation EMEA/H/C/607/II/30/G
Updated with Decision(2014)5244 of 18/07/2014
30/06/2014 Centralised - Notification EMEA/H/C/607/N/36
Updated with Decision(2014)5244 of 18/07/2014
22/07/2014 Centralised - Yearly update (2014)5244 of 18/07/2014