Somatropin Biopartners

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Lapsed

This medicine's authorisation has lapsed

somatropin
MedicineHumanLapsed
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

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.

Somatropin Biopartners : EPAR - Summary for the public

Reference Number: EMA/338086/2013

English (EN) (544.61 KB - PDF)

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български (BG) (632.75 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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español (ES) (547.19 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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čeština (CS) (611.68 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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dansk (DA) (545.4 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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Deutsch (DE) (549.15 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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eesti keel (ET) (541.08 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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ελληνικά (EL) (652.58 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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français (FR) (549.71 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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hrvatski (HR) (565.1 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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italiano (IT) (1006.58 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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latviešu valoda (LV) (692.16 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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lietuvių kalba (LT) (571.18 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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magyar (HU) (605.47 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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Malti (MT) (613.95 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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Nederlands (NL) (542.61 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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polski (PL) (609.29 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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português (PT) (543 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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română (RO) (571.28 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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slovenčina (SK) (610.49 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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slovenščina (SL) (601.17 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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Suomi (FI) (542.12 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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svenska (SV) (542.4 KB - PDF)

First published: 09/09/2013Last updated: 01/12/2017
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Product information

Somatropin Biopartners : EPAR - Product Information

English (EN) (1.19 MB - PDF)

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български (BG) (3.42 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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español (ES) (1.43 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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čeština (CS) (2.79 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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dansk (DA) (1.35 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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Deutsch (DE) (1.46 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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eesti keel (ET) (1.46 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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ελληνικά (EL) (3.53 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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français (FR) (1.5 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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hrvatski (HR) (1.36 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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íslenska (IS) (1.38 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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italiano (IT) (2.26 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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latviešu valoda (LV) (2.75 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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lietuvių kalba (LT) (1.4 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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magyar (HU) (2.76 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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Malti (MT) (2.71 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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Nederlands (NL) (1.42 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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norsk (NO) (1.44 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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polski (PL) (2.81 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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português (PT) (1.39 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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română (RO) (1.43 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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slovenčina (SK) (2.82 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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slovenščina (SL) (2.64 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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Suomi (FI) (1.39 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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svenska (SV) (1.37 MB - PDF)

First published: 09/09/2013Last updated: 27/04/2017
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Latest procedure affecting product information: IAIN/0010
13/03/2017
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Somatropin Biopartners : EPAR - All Authorised presentations

English (EN) (485.58 KB - PDF)

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български (BG) (522.76 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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español (ES) (487.33 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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čeština (CS) (519.22 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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dansk (DA) (482.58 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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Deutsch (DE) (488.45 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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eesti keel (ET) (480.38 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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ελληνικά (EL) (522.93 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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français (FR) (488.47 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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hrvatski (HR) (502.63 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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íslenska (IS) (481.1 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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italiano (IT) (938.77 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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latviešu valoda (LV) (533.71 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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lietuvių kalba (LT) (489.01 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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magyar (HU) (500.28 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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Malti (MT) (519.63 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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Nederlands (NL) (488 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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norsk (NO) (488.48 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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polski (PL) (533.01 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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português (PT) (483.2 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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română (RO) (504.85 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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slovenčina (SK) (531.76 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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slovenščina (SL) (509.05 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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Suomi (FI) (482.04 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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svenska (SV) (481.05 KB - PDF)

First published: 09/09/2013Last updated: 09/09/2013
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Product details

Name of medicine
Somatropin Biopartners
Active substance
somatropin
International non-proprietary name (INN) or common name
somatropin
Therapeutic area (MeSH)
Growth
Anatomical therapeutic chemical (ATC) code
H01AC01

Pharmacotherapeutic group

  • Somatropin and somatropin agonists
  • Pituitary and hypothalamic hormones and analogues

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.

Authorisation details

EMA product number
EMEA/H/C/002196
Marketing authorisation holder
BioPartners GmbH

Kaiserpassage 11
D-72764 Reutlingen
Germany

Marketing authorisation issued
05/08/2013
Lapse of marketing authorisation
09/11/2017
Revision
3

Assessment history

Somatropin Biopartners : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (572.08 KB - PDF)

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Somatropin Biopartners : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/229458/2013

English (EN) (2.79 MB - PDF)

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More information on Somatropin Biopartners

Public statement on Somatropin Biopartners: Cessation of validity of the marketing authorisation in the European Union

Reference Number: EMA/791271/2017

English (EN) (73.22 KB - PDF)

First published: Last updated:
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