Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone
Table of contents
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.
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Nitisinone MDK (previously Nitisinone MendeliKABS) : EPAR - Summary for the public (PDF/93.32 KB)
First published: 05/10/2017
Last updated: 05/10/2017
EMA/649866/2017 -
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Nitisinone MDK : EPAR - Risk management plan summary (PDF/129.92 KB)
First published: 24/03/2022
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 and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
MendeliKABS Europe Ltd
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
24/08/2017
|
Contact address |
Unit 3D, North Point House |
Product information
15/07/2022 Nitisinone MDK (previously Nitisinone MendeliKABS) - EMEA/H/C/004281 - R/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.