Mirapexin

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pramipexole

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Mirapexin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mirapexin.

This EPAR was last updated on 11/07/2018

Authorisation details

Product details
Name
Mirapexin
Agency product number
EMEA/H/C/000134
Active substance
pramipexole dihydrochloride monohydrate
International non-proprietary name (INN) or common name
pramipexole
Therapeutic area (MeSH)
  • Restless Legs Syndrome
  • Parkinson Disease
Anatomical therapeutic chemical (ATC) code
N04BC05
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
23/02/1998
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

20/06/2018 Mirapexin - EMEA/H/C/000134 - N/0087

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti Parkinson drugs

Therapeutic indication

Mirapexin is indicated 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).

Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

Assessment history

Changes since initial authorisation of medicine

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