Pramipexole Accord

Withdrawn

This medicine's authorisation has been withdrawn

pramipexole

Overview

On 13 April 2022, the European Commission withdrew the marketing authorisation for Pramipexole Accord (pramipexole) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Accord Healthcare S.L.U., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pramipexole Accord was granted marketing authorisation in the EU on 30 September 2011 for the treatment of idiopathic Parkinson’s disease and restless legs syndrome. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016. 

Pramipexole Accord is a generic medicine of Mirapexin. There are other generic medicinal products of Mirapexin authorised and marketed in the EU. 

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Public Assessment Report (EPAR) for Pramipexole Accord is updated to indicate that the marketing authorisation is no longer valid.

Pramipexole Accord : EPAR - Summary for the public

Reference Number: EMA/684920/2011

Product information

Pramipexole Accord : EPAR - Product Information

Pramipexole Accord : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pramipexole Accord
• Active substance:
  pramipexole dihydrochloride monohydrate
• International non-proprietary name (INN) or common name:
  pramipexole
• Therapeutic area (MeSH):
  • Parkinson Disease
  • Restless Legs Syndrome
• Anatomical therapeutic chemical (ATC) code:
  N04BC05

Pharmacotherapeutic group

Anti-Parkinson drugs

Therapeutic indication

Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

Authorisation details

• EMA product number:
  EMEA/H/C/002291
• 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:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  21/07/2011
• Marketing authorisation issued:
  29/09/2011
• Withdrawal of marketing authorisation:
  13/04/2022
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Pramipexole Accord : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pramipexole Accord : EPAR - Public assessment report

Adopted Reference Number: EMA/816841/2011

CHMP summary of positive opinion for Pramipexole Accord

Adopted Reference Number: EMA/CHMP/507521/2011