Nitisinone MDK (previously Nitisinone MendeliKABS)

Withdrawn

This medicine's authorisation has been withdrawn

nitisinone

Overview

The marketing authorisation for Nitisinone MDK has been withdrawn at the request of the marketing-authorisation holder.

Nitisinone MDK (previously Nitisinone MendeliKABS) : EPAR - Summary for the public

Reference Number: EMA/649866/2017

Nitisinone MDK : EPAR - Risk management plan summary

Product information

Nitisinone MDK : EPAR - Product Information

Latest procedure affecting product information: R/0013

15/07/2022

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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).

Nitisinone MDK (previously Nitisinone MendeliKABS) : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nitisinone MDK (previously Nitisinone MendeliKABS)
• Active substance:
  nitisinone
• International non-proprietary name (INN) or common name:
  nitisinone
• Therapeutic area (MeSH):
  Tyrosinemias
• Anatomical therapeutic chemical (ATC) code:
  A16AX04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004281
• 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.

• Marketing authorisation holder:
  MendeliKABS Europe Ltd

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

• Opinion adopted:
  22/06/2017
• Marketing authorisation issued:
  24/08/2017
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Nitisinone MDK (previously Nitisinone MendeliKABS) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Nitisinone MendeliKABS : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/502860/2017

CHMP summary of positive opinion for Nitisinone MendeliKABS

AdoptedReference Number: EMA/CHMP/368249/2017