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 12/08/2022

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
36
Date of issue of marketing authorisation valid throughout the European Union
13/10/1997
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

16/12/2021 Sifrol - EMEA/H/C/000133 - WS2169

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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