Valtropin

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somatropin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 14/08/2012

Authorisation details

Product details
Name
Valtropin
Agency product number
EMEA/H/C/000602
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
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.

Publication details
Marketing-authorisation holder
BioPartners GmbH
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
24/04/2006
Contact address
Kaiserpassage 11
D-72764 Reutlingen
Germany

Product information

10/05/2012 Valtropin - EMEA/H/C/000602 - A20/08

Contents

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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.

Assessment history

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