Nitisinone MDK (previously Nitisinone MendeliKABS)

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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 Nitisinone MDK. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nitisinone MDK.

For practical information about using Nitisinone MDK, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 14/05/2018

Authorisation details

Product details
Name
Nitisinone MDK (previously Nitisinone MendeliKABS)
Agency product number
EMEA/H/C/004281
Active substance
nitisinone
International non-proprietary name (INN) or common name
nitisinone
Therapeutic area (MeSH)
Tyrosinemias
Anatomical therapeutic chemical (ATC) code
A16AX04
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
MendeliKABS Europe Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
24/08/2017
Contact address
The Light Box111
Power RdUnit G. 07
Chiswick
London
W4 5PY
United Kingdom

Product information

21/04/2018 Nitisinone MDK (previously Nitisinone MendeliKABS) - EMEA/H/C/004281 - IB/0002/G

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

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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