Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Valtropin
Auth. number : EU/1/06/335
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: Paediatric patients
- Long-term treatment of children 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.
Marketing Authorisation Holder: BioPartners GmbH
Kaiserpassage 11, D-72764 Reutlingen, Deutschland
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
26/04/2006 Centralised - Authorisation EMEA/H/C/602 (2006)1742 of 24/04/2006
19/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/602/IA/1
11/01/2008 Centralised - Variation EMEA/H/C/602/IB/3
Updated with Decision(2008)4100 of 25/07/2008
13/08/2008 Centralised - Variation (2008)4100 of 25/07/2008
21/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/602/IB/5
05/11/2008 Centralised - Variation EMEA/H/C/602/II/4 (2008)6489 of 28/10/2008
09/06/2009 Centralised - Variation EMEA/H/C/602/IA/6
Updated with Decision(2010)1776 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1776 of 15/03/2010
21/04/2011 Centralised - Renewal EMEA/H/C/602/R/7 (2011)2862 of 18/04/2011
06/03/2012 Referral EMEA/H/C/602/A-20/8 (2012)1503 of 02/03/2012
14/05/2012 Centralised - Withdrawal (2012)3208 of 10/05/2012