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.
Nityr : EPAR - Medicine overview (PDF/91.15 KB)
First published: 09/08/2018
Last updated: 09/08/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Cycle Pharmaceuticals Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
26/07/2018 Nityr - EMEA/H/C/004582 - -
- 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.
Other alimentary tract and metabolism products
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.