NutropinAq

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somatropin

Authorised
This medicine is authorised for use in the European Union.

Overview

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).

This EPAR was last updated on 20/07/2023

Authorisation details

Product details
Name
NutropinAq
Agency product number
EMEA/H/C/000315
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
Publication details
Marketing-authorisation holder
Ipsen Pharma
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
15/02/2001
Contact address
65, quai Georges Gorse
F-92100 Boulogne-Billancourt
France

Product information

20/07/2023 NutropinAq - EMEA/H/C/000315 - N/0079

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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

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.

Assessment history

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