This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
NutropinAq : EPAR - Summary for the public (PDF/81.1 KB)
First published: 18/01/2007
Last updated: 06/06/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
65, quai Georges Gorse
20/07/2023 NutropinAq - EMEA/H/C/000315 - N/0079
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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).
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Pituitary and hypothalamic hormones and analogues
Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.
Long-term treatment of growth failure associated with Turner syndrome.
Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation.
Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.