Orfadin

RSS

nitisinone

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

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.

This EPAR was last updated on 01/03/2021

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
20
Date of issue of marketing authorisation valid throughout the European Union
20/02/2005
Contact address
SE-112 76 Stockholm
Sweden

Product information

22/10/2020 Orfadin - EMEA/H/C/000555 - II/0071

Contents

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).

Assessment history

Related content

How useful was this page?

Add your rating
Average
1 rating