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.
Sifrol : EPAR - Summary for the public (PDF/126.65 KB)
First published: 17/11/2009
Last updated: 05/01/2011
Sifrol : EPAR - Risk-management-plan summary (PDF/91.1 KB)
First published: 20/05/2019
|Agency product number||
pramipexole dihydrochloride monohydrate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
11/04/2019 Sifrol - EMEA/H/C/000133 - WS/1510
- 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
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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).