Somatropin Biopartners

somatropin

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This marketing authorisation for Somatropin Biopartners has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Name Language First published Last updated
Somatropin Biopartners : EPAR - Summary for the public BG = bălgarski 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public ES = español 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public CS = čeština 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public DA = dansk 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public DE = Deutsch 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public ET = eesti keel 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public EL = elliniká 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public EN = English 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public FR = français 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public IT = italiano 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public LV = latviešu valoda 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public LT = lietuvių kalba 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public HU = magyar 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public MT = Malti 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public NL = Nederlands 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public PL = polski 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public PT = português 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public RO = română 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public SK = slovenčina 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public SL = slovenščina 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public FI = suomi 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public SV = svenska 2013-09-09 2017-12-01
Somatropin Biopartners : EPAR - Summary for the public HR = Hrvatski 2013-09-09 2017-12-01

This EPAR was last updated on 01/12/2017 .

Authorisation details

Product details

Product details for Somatropin Biopartners
NameSomatropin Biopartners
Agency product numberEMEA/H/C/002196
Active substance

somatropin

International non-proprietary name (INN) or common name

somatropin

Therapeutic area Growth
Anatomical therapeutic chemical (ATC) code H01AC01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Somatropin Biopartners
Marketing-authorisation holder

BioPartners GmbH

Revision3
Date of issue of marketing authorisation valid throughout the European Union05/08/2013

Contact address:

BioPartners GmbH
Kaiserpassage 11
D-72764 Reutlingen
Germany

Product information

Product information

13/03/2017  Somatropin Biopartners -EMEA/H/C/002196 -IAIN/0010

Name Language First published Last updated
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27
Somatropin Biopartners : EPAR - Product Information HR = Hrvatski 2013-09-09 2017-04-27

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
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  
Somatropin Biopartners : EPAR - All Authorised presentations HR = Hrvatski 2013-09-09  

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues, somatropin and agonists

Therapeutic indication

Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD).

Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.

Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) 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
Somatropin Biopartners : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-07-30 2017-04-27

Initial marketing-authorisation documents

Name Language First published Last updated
Somatropin Biopartners : EPAR - Public assessment report HR = Hrvatski 2013-09-09  
CHMP summary of positive opinion for Somatropin Biopartners HR = Hrvatski 2013-05-31  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Somatropin Biopartners