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 14/04/2023

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
21
Date of issue of marketing authorisation valid throughout the European Union
21/02/2005
Contact address
SE-112 76 Stockholm
Sweden

Product information

13/04/2023 Orfadin - EMEA/H/C/000555 - IB/0082

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Product information documents contain:

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

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

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