Nityr

RSS

nitisinone

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

Overview

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

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.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
Nityr
Agency product number
EMEA/H/C/004582
Active substance
nitisinone
International non-proprietary name (INN) or common name
nitisinone
Therapeutic area (MeSH)
Tyrosinemias
Anatomical therapeutic chemical (ATC) code
A16AX04
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Cycle Pharmaceuticals Ltd
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
26/07/2018
Contact address
Bailey Grundy Barrett Building
Little St Mary's Lane
Cambridge
United Kingdom

Product information

26/07/2018 Nityr - EMEA/H/C/004582 - -

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

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

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