Valtropin

Withdrawn

This medicine's authorisation has been withdrawn

somatropin

Overview

The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.

Valtropin : EPAR - Summary for the public

Product information

Valtropin : EPAR - Product Information

Latest procedure affecting product information: A20/08

10/05/2012

This medicine’s product information is available in all official EU languages.
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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).

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
• 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