Nitisinone MDK (previously Nitisinone MendeliKABS)

Withdrawn

This medicine's authorisation has been withdrawn

nitisinone

Overview

On 31 March 2023, the European Commission withdrew the marketing authorisation for Nitisinone MDK (nitisinone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, MendeliKABS Europe Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product in the EU for commercial reasons. 

Nitisinone MDK was granted marketing authorisation in the EU on 24 August 2017 for the treatment of hereditary tyrosinaemia type 1 (HT-1). The marketing authorisation was initially valid for a 5-year period. It was granted unlimited validity in 2022. 

Nitisinone MDK is a generic medicine of Orfadin. There are other generic medicinal products of Orfadin authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Nitisinone MDK is updated to indicate that the marketing authorisation is no longer valid.

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

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

Adopted Reference Number: EMA/CHMP/502860/2017

CHMP summary of positive opinion for Nitisinone MendeliKABS

Adopted Reference Number: EMA/CHMP/368249/2017