Natpar

parathyroid hormone

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This is a summary of the European public assessment report (EPAR) for Natpar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Natpar.

For practical information about using Natpar, patients should read the package leaflet or contact their doctor or pharmacist.

What is Natpar and what is it used for?

Natpar is a hormone replacement medicine for treating adults with under-active parathyroid glands, a condition known as hypoparathyroidism.

In patients with this condition, the parathyroid glands in the neck do not produce enough parathyroid hormone which controls the level of calcium in the blood. As a result, patients have low levels of calcium which can cause problems in bones, muscles, heart, kidneys and other parts of the body.

Natpar is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.

Because the number of patients with hypoparathyroidism is low, the disease is considered ‘rare’, and Natpar was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 December 2013.

Natpar contains the active substance parathyroid hormone.

How is Natpar used?

Natpar is available as a powder and a liquid that are mixed together to make a solution for injection. Natpar is injected under the skin of the thigh using the Natpar pen. The usual recommended starting dose is 50 micrograms once a day. The dose of Natpar, as well as the patient’s dose of the vitamin D and calcium supplements, is then adjusted on the basis of the patient’s blood calcium levels. The maximum daily dose is 100 micrograms.

Patients can inject Natpar themselves once they have been trained. The medicine can only be obtained with a prescription and treatment should be supervised by a healthcare professional experienced in the management of patients with hypoparathyroidism. For further information, see the package leaflet.

How does Natpar work?

The active substance in Natpar, parathyroid hormone, is a copy of the natural hormone produced by the parathyroid glands. It replaces the missing hormone in patients with hypoparathyroidism, thus helping to restore calcium levels.

What benefits of Natpar have been shown in studies?

Natpar has been shown to help control blood calcium levels in patients with hypoparathyroidism who are receiving calcium and vitamin D supplements.

In a main 24-week study involving 124 patients, 54.8% (46 out of 84) of the patients who received Natpar achieved and maintained acceptable blood calcium levels while reducing their doses of calcium and vitamin D supplements by at least 50%. The proportion of patients taking placebo (a dummy treatment) who achieved the same was 2.5% (1 out of 40 patients).

What are the risks associated with Natpar?

The most common side effects with Natpar (which may affect more than 1 in 10 people) are too high or too low blood calcium levels, which can lead to headache, diarrhoea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch) and high calcium levels in the urine. For the full list of all side effects reported with Natpar, see the package leaflet.

Natpar must not be used in patients who are having or have had radiation therapy to the bones, who have bone cancer or cancer that has spread to the bones and are at increased risk of developing a bone cancer called osteosarcoma. Natpar must also not be used in patients who have unexplained increases in the levels of an enzyme called bone alkaline phosphatase and those who have pseudohypoparathyroidism, a rare disease where the body does not respond adequately to the parathyroid hormone produced by the body. For the full list of restrictions, see the package leaflet.

Why is Natpar approved?

Natpar replaces the missing parathyroid hormone in patients with hypoparathyroidism. While the main study showed that Natpar helps control blood calcium levels while reducing the need for calcium and vitamin D supplements, the study was of short duration and there was no evidence of improvements in patients’ quality of life or reductions in long-term problems such as kidney impairment. Therefore, Natpar should only be used in patients who are not adequately controlled with standard treatments alone, who do not have other treatment options.

Regarding safety, the risk of calcium levels becoming too high or too low is considered important and further data are needed to better understand the consequences of wide fluctuations in blood calcium level after the medicine is given once a day.

Because of the limited data available, Natpar has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Natpar?

Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-a-day dosing schedule.

What measures are being taken to ensure the safe and effective use of Natpar?

The company that markets Natpar will set-up a registry and collect long-term data on patients treated with Natpar, including its effects on bones, kidneys and patients’ quality of life.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Natpar have also been included in the summary of product characteristics and the package leaflet.

Other information about Natpar

The European Commission granted a marketing authorisation valid throughout the European Union for Natpar on 24 April 2017.

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

Name Language First published Last updated
Natpar : EPAR - Summary for the public BG = bălgarski 2017-04-26  
Natpar : EPAR - Summary for the public ES = español 2017-04-26  
Natpar : EPAR - Summary for the public CS = čeština 2017-04-26  
Natpar : EPAR - Summary for the public DA = dansk 2017-04-26  
Natpar : EPAR - Summary for the public DE = Deutsch 2017-04-26  
Natpar : EPAR - Summary for the public ET = eesti keel 2017-04-26  
Natpar : EPAR - Summary for the public EL = elliniká 2017-04-26  
Natpar : EPAR - Summary for the public EN = English 2017-04-26  
Natpar : EPAR - Summary for the public FR = français 2017-04-26  
Natpar : EPAR - Summary for the public IT = italiano 2017-04-26  
Natpar : EPAR - Summary for the public LV = latviešu valoda 2017-04-26  
Natpar : EPAR - Summary for the public LT = lietuvių kalba 2017-04-26  
Natpar : EPAR - Summary for the public HU = magyar 2017-04-26  
Natpar : EPAR - Summary for the public MT = Malti 2017-04-26  
Natpar : EPAR - Summary for the public NL = Nederlands 2017-04-26  
Natpar : EPAR - Summary for the public PL = polski 2017-04-26  
Natpar : EPAR - Summary for the public PT = português 2017-04-26  
Natpar : EPAR - Summary for the public RO = română 2017-04-26  
Natpar : EPAR - Summary for the public SK = slovenčina 2017-04-26  
Natpar : EPAR - Summary for the public SL = slovenščina 2017-04-26  
Natpar : EPAR - Summary for the public FI = suomi 2017-04-26  
Natpar : EPAR - Summary for the public SV = svenska 2017-04-26  
Natpar : EPAR - Summary for the public HR = Hrvatski 2017-04-26  

This EPAR was last updated on 19/07/2017 .

Authorisation details

Product details

Product details for Natpar
NameNatpar
Agency product numberEMEA/H/C/003861
Active substance

parathyroid hormone

International non-proprietary name (INN) or common name

parathyroid hormone

Therapeutic area Hypoparathyroidism
Anatomical therapeutic chemical (ATC) code H05AA03
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Natpar
Marketing-authorisation holder

Shire Pharmaceuticals Ireland Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union24/04/2017

Contact address:

Shire Pharmaceuticals Ireland Ltd
5 Riverwalk Citywest 
Business Campus 
Dublin 24 
Ireland

Product information

Product information

14/06/2017  Natpar -EMEA/H/C/003861 -IAIN/0003/G

Name Language First published Last updated
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19
Natpar : EPAR - Product Information HR = Hrvatski 2017-04-26 2017-07-19

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.


Name Language First published Last updated
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  
Natpar : EPAR - All Authorised presentations HR = Hrvatski 2017-04-26  

Pharmacotherapeutic group

Calcium homeostasis

Therapeutic indication

Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Natpar : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-07-19  

Initial marketing-authorisation documents

Name Language First published Last updated
Natpar : EPAR - Public assessment report HR = Hrvatski 2017-04-26  
CHMP summary of positive opinion for Natpar HR = Hrvatski 2017-02-24