Valtropin

somatropin

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The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Valtropin : EPAR - Summary for the public BG = bălgarski 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public ES = español 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public CS = čeština 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public DA = dansk 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public DE = Deutsch 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public ET = eesti keel 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public EL = elliniká 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public EN = English 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public FR = français 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public IT = italiano 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public LV = latviešu valoda 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public LT = lietuvių kalba 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public HU = magyar 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public MT = Malti 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public NL = Nederlands 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public PL = polski 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public PT = português 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public RO = română 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public SK = slovenčina 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public SL = slovenščina 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public FI = suomi 31/05/2007 14/08/2012
Valtropin : EPAR - Summary for the public SV = svenska 31/05/2007 14/08/2012

This EPAR was last updated on 14/08/2012 .

Authorisation details

Product details

Product details for Valtropin
NameValtropin
Agency product numberEMEA/H/C/000602
Active substance

somatropin

International non-proprietary name (INN) or common name

somatropin

Therapeutic area Dwarfism, 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 Valtropin
Marketing-authorisation holder

BioPartners GmbH

Revision5
Date of issue of marketing authorisation valid throughout the European Union24/04/2006

Contact address:

BioPartners GmbH
Kaiserpassage 11
D-72764 Reutlingen
Germany

Product information

Product information

10/05/2012  Valtropin -EMEA/H/C/000602 -A20/08

Name Language First published Last updated
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012
Valtropin : EPAR - Product Information SV = svenska 17/06/2009 14/08/2012

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
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012
Valtropin : EPAR - All Authorised presentations SV = svenska 27/08/2008 14/08/2012

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Paediatric poulation

  • Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.
  • Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.
  • Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.

Adult patients

  • Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.

Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), 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

Name Language First published Last updated
Valtropin-H-C-620-A20-08 : EPAR - Assessment Report - Variation SV = svenska 03/08/2012 14/08/2012
Valtropin : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 17/06/2009 14/08/2012

Initial marketing-authorisation documents

Name Language First published Last updated
Valtropin : EPAR - Procedural steps taken before authorisation SV = svenska 31/05/2007 14/08/2012
Valtropin : EPAR - Scientific Discussion SV = svenska 31/05/2007 14/08/2012

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Valtropin