Nityr

nitisinone

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An overview of Nityr and why it is authorised in the EU

What is Nityr and what is it used for?

Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1). This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and, as a result, harmful substances are formed, causing serious liver problems and liver cancer.

Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine. These amino acids are normally found in proteins in foods and drinks.

Nityr contains the active substance nitisinone and is a ‘generic medicine’. This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Orfadin.

How is Nityr used?

Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1. Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient’s response and body weight.

Nityr is available as 10 mg tablets to be taken by mouth. The recommended starting dose is 1 mg per kilogram body weight per day.

Nityr is intended for long-term use. Patients should be monitored at least every six months.

For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist.

How does Nityr work?

Tyrosine is broken down in the body by a number of enzymes. Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is converted into harmful substances. The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances. However, as the unconverted tyrosine remains in the body during Nityr treatment, patients need to eat a special diet low in tyrosine. The diet also needs to be low in phenylalanine, as this is converted to tyrosine in the body.

How has Nityr been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr.

As for every medicine, the company provided studies on the quality of Nityr. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Nityr?

Because Nityr is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Nityr authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin. Therefore, the Agency’s view was that, as for Orfadin, the benefit of Nityr outweighs the identified risk and it can be authorised for use in the EU.

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

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

As for all medicines, data on the use of Nityr are continuously monitored. Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients.

Other information about Nityr

Nityr received a marketing authorisation valid throughout the EU on 26 July 2018.

Name Language First published Last updated
Nityr : EPAR - Medicine overview BG = bălgarski 2018-08-09  
Nityr : EPAR - Medicine overview ES = español 2018-08-09  
Nityr : EPAR - Medicine overview CS = čeština 2018-08-09  
Nityr : EPAR - Medicine overview DA = dansk 2018-08-09  
Nityr : EPAR - Medicine overview DE = Deutsch 2018-08-09  
Nityr : EPAR - Medicine overview ET = eesti keel 2018-08-09  
Nityr : EPAR - Medicine overview EL = elliniká 2018-08-09  
Nityr : EPAR - Medicine overview EN = English 2018-08-09  
Nityr : EPAR - Medicine overview FR = français 2018-08-09  
Nityr : EPAR - Medicine overview IT = italiano 2018-08-09  
Nityr : EPAR - Medicine overview LV = latviešu valoda 2018-08-09  
Nityr : EPAR - Medicine overview LT = lietuvių kalba 2018-08-09  
Nityr : EPAR - Medicine overview HU = magyar 2018-08-09  
Nityr : EPAR - Medicine overview MT = Malti 2018-08-09  
Nityr : EPAR - Medicine overview NL = Nederlands 2018-08-09  
Nityr : EPAR - Medicine overview PL = polski 2018-08-09  
Nityr : EPAR - Medicine overview PT = português 2018-08-09  
Nityr : EPAR - Medicine overview RO = română 2018-08-09  
Nityr : EPAR - Medicine overview SK = slovenčina 2018-08-09  
Nityr : EPAR - Medicine overview SL = slovenščina 2018-08-09  
Nityr : EPAR - Medicine overview FI = suomi 2018-08-09  
Nityr : EPAR - Medicine overview SV = svenska 2018-08-09  
Nityr : EPAR - Medicine overview HR = Hrvatski 2018-08-09  

This EPAR was last updated on 09/08/2018 .

Authorisation details

Product details

Product details for Nityr
NameNityr
Agency product numberEMEA/H/C/004582
Active substance

nitisinone

International non-proprietary name (INN) or common name

nitisinone

Therapeutic area Tyrosinemias
Anatomical therapeutic chemical (ATC) code A16AX04
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.

Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Nityr
Marketing-authorisation holder

Cycle Pharmaceuticals Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union26/07/2018

Contact address:

Cycle Pharmaceuticals Ltd
Bailey Grundy Barrett Building
Little St Mary's Lane
Cambridge
United Kingdom

Product information

Product information

26/07/2018  Nityr -EMEA/H/C/004582 --

Name Language First published Last updated
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  
Nityr : EPAR - Product Information HR = Hrvatski 2018-08-09  

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
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  
Nityr : EPAR - All Authorised presentations HR = Hrvatski 2018-08-09  

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Nityr : EPAR - Public assessment report HR = Hrvatski 2018-08-09  
CHMP summary of positive opinion for Nityr HR = Hrvatski 2018-06-01  

Authorised

This medicine is approved for use in the European Union