Basic Information
Nityr
Regulatory Information
EMEA/H/C/004582
July 26, 2018
May 31, 2018
5
June 5, 2023
Company Information
Cycle Pharmaceuticals (Europe) Ltd,70 Sir John Rogerson's Quay,Dublin 2,Ireland
Ireland
70 Sir John Rogerson's Quay Dublin 2
cycle pharmaceuticals (europe) ltd
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.