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).

NutropinAq is a solution for injection in a cartridge. Each cartridge contains 10 mg of the active substance somatropin.

NutropinAq is used to treat the following groups of children:

  • children who fail to grow because of a lack of growth hormone;
  • girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
  • children (before puberty), who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.

NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone. The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.

The medicine can only be obtained with a prescription.

NutropinAq treatment should be started and supervised by a doctor who has experience in the management of patients with growth disorders.

The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge. The patient or their carer can inject NutropinAq after training by a doctor or a nurse. They should use a different injection site each day. The doctor calculates the dose for each patient individually depending on the patient’s condition. The dose may need to be adjusted over time, depending on the patient’s response, age and body weight.

Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland. It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates. The active substance in NutropinAq, somatropin, is identical to human growth hormone. It is produced by a method known as ‘recombinant DNA technology’: the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin. NutropinAq replaces the natural hormone.

NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients). NutropinAq has also been studied in 171 adults with growth hormone deficiency. NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients, except in the studies of children with a lack of growth hormone where there was no comparison with any other group. The main measures in the studies in children were the speed of growth during the study and the height at the end of the study. The main measures in the adult study were lean body mass and the decrease in total body fat.

NutropinAq produced better growth in children than would have been expected without treatment. In adults, NutropinAq increased lean body mass and reduced total body fat.

In adults, the most common side effects with NutropinAq (seen in more than 1 patient in 10) are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling). In children, these side effects are seen in between 1 and 10 patients in 100. Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq). The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull). For the full list of all side effects reported with NutropinAq, see the package leaflet.

NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other ingredients. NutropinAq must not be used when the patient has an active tumour or a life-threatening illness. NutropinAq must not be used for growth promotion in children with closed epiphyses (when the large bones have finished growing). For the full list of restrictions, see the package leaflet.

Somatropin may interfere with the body’s use of insulin. Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be started or adjusted.

The CHMP concluded that NutropinAq’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq on on 16 February 2001.

For more information about treatment with NutropinAq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

NutropinAq : EPAR - Summary for the public

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Product information

NutropinAq : EPAR - Product Information

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Latest procedure affecting product information: N/0079

20/07/2023

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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).

NutropinAq : EPAR - All Authorised presentations

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Product details

Name of medicine
NutropinAq
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

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.

Authorisation details

EMA product number
EMEA/H/C/000315
Marketing authorisation holder
Ipsen Pharma

65, quai Georges Gorse
F-92100 Boulogne-Billancourt
France

Marketing authorisation issued
15/02/2001
Revision
20

Assessment history

NutropinAq : EPAR - Procedural steps taken and scientific information after authorisation

NutropinAq-H-C-PSUSA-00002772-202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

NutropinAq-H-C-PSUSA-00002772-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Questions and answers on recommendation for the refusal of a change to the marketing authorisation for NutropinAq

NutropinAq : EPAR - Scientific Discussion

NutropinAq : EPAR - Procedural steps taken before authorisation

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