Nityr
nitisinone
Table of contents
Overview
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.
-
List item
Nityr : EPAR - Medicine overview (PDF/91.15 KB)
First published: 09/08/2018
Last updated: 09/08/2018 -
-
List item
Nityr : EPAR - Risk management plan summary (PDF/618.95 KB)
First published: 15/12/2022
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 and hybrid medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Cycle Pharmaceuticals (Europe) Ltd
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
26/07/2018
|
Contact address |
70 Sir John Rogerson's Quay |
Product information
28/11/2022 Nityr - EMEA/H/C/004582 - IB/0014
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.