Orfadin

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nitisinone

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

Overview

This is a summary of the European public assessment report (EPAR) for Orfadin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orfadin.

This EPAR was last updated on 11/12/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum International AB
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
20/02/2005
Contact address
SE-112 76 Stockholm
Sweden

Product information

20/11/2018 Orfadin - EMEA/H/C/000555 - PSUSA/00002169/201802

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

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.

Assessment history

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