Orfadin
nitisinone
Table of contents
Overview
Orfadin is a medicine for the treatment of:
- hereditary tyrosinaemia type 1 (HT‑1) in patients of all ages who also follow diet restrictions;
- alkaptonuria (AKU) in adults.
These diseases occur when the body cannot fully break down certain amino acids including tyrosine. As a result, harmful substances build up, which can cause serious liver problems and liver cancer in patients with HT-1 and joint problems in patients with AKU.
Orfadin contains the active substance nitisinone.
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List item
Orfadin : EPAR - Summary for the public (PDF/144.36 KB) (updated)
First published: 10/11/2009
Last updated: 11/01/2021
EMA/602143/2020 -
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List item
Orfadin : EPAR - Risk-management-plan summary (PDF/75.39 KB)
First published: 03/11/2020
Authorisation details
Product details | |
---|---|
Name |
Orfadin
|
Agency product number |
EMEA/H/C/000555
|
Active substance |
nitisinone
|
International non-proprietary name (INN) or common name |
nitisinone
|
Therapeutic area (MeSH) |
Tyrosinemias
|
Anatomical therapeutic chemical (ATC) code |
A16AX04
|
Publication details | |
---|---|
Marketing-authorisation holder |
Swedish Orphan Biovitrum International AB
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
20/02/2005
|
Contact address |
Product information
22/10/2020 Orfadin - EMEA/H/C/000555 - II/0071
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
Hereditary tyrosinemia type 1 (HT 1)
Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.
Alkaptonuria (AKU)
Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).