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 06/12/2018

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
30
Date of issue of marketing authorisation valid throughout the European Union
13/10/1997
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

20/06/2018 Sifrol - EMEA/H/C/000133 - N/0078

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

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