Valtropin

Withdrawn

This medicine's authorisation has been withdrawn

somatropin

Overview

On 24 April 2006 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Valtropin (somatropin), which had been approved for the treatment of children in the following situations:

• children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
• children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
• children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency). 

Valtropin was also approved for the treatment of adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy). The marketing authorisation holder (MAH) responsible for Valtropin was BioPartners GmbH. 

The European Commission was notified by a letter dated 31 October 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation for commercial reasons. Valtropin was not marketed in any EU country. On 10 May 2012 the European Commission issued a decision to withdraw the marketing authorisation for Valtropin. 

Pursuant to this decision the European Public Assessment Report for Valtropin is updated to reflect that the marketing authorisation is no longer valid.

Valtropin : EPAR - Summary for the public

Product information

Valtropin : EPAR - Product Information

Valtropin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Valtropin
• Active substance:
  somatropin
• International non-proprietary name (INN) or common name:
  somatropin
• Therapeutic area (MeSH):
  • Turner Syndrome
  • Dwarfism, Pituitary
• Anatomical therapeutic chemical (ATC) code:
  H01AC01

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000602
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  BioPartners GmbH

  Kaiserpassage 11; D-72764 Reutlingen; Germany

• Marketing authorisation issued:
  24/04/2006
• Withdrawal of marketing authorisation:
  10/05/2012
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Valtropin : EPAR - Procedural steps taken and scientific information after authorisation

Valtropin-H-C-620-A20-08 : EPAR - Assessment Report - Variation

Adopted

Initial marketing authorisation documents

Valtropin : EPAR - Procedural steps taken before authorisation

Valtropin : EPAR - Scientific Discussion