Nitisinone MDK (previously Nitisinone MendeliKABS)



This medicine is authorised for use in the European Union.


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 20/02/2023

Authorisation details

Product details
Nitisinone MDK (previously Nitisinone MendeliKABS)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code

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 and hybrid medicines.

Publication details
Marketing-authorisation holder
MendeliKABS Europe Ltd
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Unit 3D, North Point House
North Point Business Park
New Mallow Road
Cork, T23 AT2P, Ireland

Product information

15/07/2022 Nitisinone MDK (previously Nitisinone MendeliKABS) - EMEA/H/C/004281 - R/0013

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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

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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