Valtropin
somatropin
Table of contents
Overview
The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.
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) |
|
| 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
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:
- 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).
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.