This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.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
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Turner Syndrome
  • Dwarfism, Pituitary
Anatomical therapeutic chemical (ATC) code

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
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Kaiserpassage 11
D-72764 Reutlingen

Product information

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

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

How useful was this page?

Add your rating
1 rating