Orfadin

RSS

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 07/02/2020

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
17
Date of issue of marketing authorisation valid throughout the European Union
20/02/2005
Contact address
SE-112 76 Stockholm
Sweden

Product information

20/12/2019 Orfadin - EMEA/H/C/000555 - IAIN/0070

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

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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