Mirapexin
pramipexole
Table of contents
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.
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Mirapexin : EPAR - Summary for the public (PDF/75.97 KB)
First published: 18/11/2009
Last updated: 06/01/2011 -
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Mirapexin : EPAR - Risk-management-plan summary (PDF/97.15 KB)
First published: 21/05/2019
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) |
|
Anatomical therapeutic chemical (ATC) code |
N04BC05
|
Publication details | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
|
Revision |
39
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Date of issue of marketing authorisation valid throughout the European Union |
23/02/1998
|
Contact address |
D-55216 Ingelheim am Rhein
Germany |
Product information
16/12/2021 Mirapexin - EMEA/H/C/000134 - WS2169
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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).