Sifrol

RSS

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 Sifrol. 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 Sifrol.

This EPAR was last updated on 22/03/2018

Authorisation details

Product details
Name
Sifrol
Agency product number
EMEA/H/C/000133
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
29
Date of issue of marketing authorisation valid throughout the European Union
14/10/1997
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

08/02/2018 Sifrol - EMEA/H/C/000133 - WS/1318

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

Sifrol 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, though 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).

Sifrol 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

  • List item

    Sifrol-H-C-PSUSA-00002491-201604 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/66.39 KB)


    First published: 01/03/2017
    Last updated: 01/03/2017
    EMA/CHMP/17308/2017

  • List item

    Sifrol-H-C-133-PSUSA-2491-201304 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/61.76 KB)


    First published: 24/03/2014
    Last updated: 24/03/2014
    EMA/157197/2014

  • List item

    Sifrol-H-C-133-P46-0040 : EPAR - Assessment Report (PDF/189.1 KB)

    Adopted

    First published: 22/04/2013
    Last updated: 22/04/2013
    EMA/161985/2013

  • List item

    Sifrol-H-C-133-X-0054 : EPAR - Assessment Report - Extension (PDF/171.71 KB)

    Adopted

    First published: 12/07/2010
    Last updated: 12/07/2010

  • List item

    Sifrol-H-C-133-X-0051 : EPAR - Assessment Report - Extension (PDF/391.16 KB)

    Adopted

    First published: 17/11/2009
    Last updated: 17/11/2009
    EMEA/703892/2009

  • List item

    CHMP post-authorisation summary of positive opinion for Sifrol on 25 June 2009 (PDF/30.33 KB)

    Adopted

    First published: 25/06/2009
    Last updated: 25/06/2009
    EMEA/CHMP/391474/2009

  • List item

    Sifrol-H-C-133-II-0030 : EPAR - Scientific Discussion - Variation (PDF/567.04 KB)

    Adopted

    First published: 12/09/2006
    Last updated: 12/09/2006

  • List item

    Sifrol : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/79.88 KB)


    First published: 26/10/2005
    Last updated: 26/10/2005

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