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 06/03/2018

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
15
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

21/02/2018 NutropinAq - EMEA/H/C/000315 - PSUSA/00002772/201703

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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