Mirapexin

Country: European Union

Language: French

Source: EMA (European Medicines Agency)

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Active ingredient:

Dichlorhydrate de pramipexole monohydraté

Available from:

Boehringer Ingelheim International GmbH

ATC code:

N04BC05

INN (International Name):

pramipexole

Therapeutic group:

Les médicaments anti-parkinsoniens

Therapeutic area:

Restless Legs Syndrome; Parkinson Disease

Therapeutic indications:

La mirapexine est indiquée pour le traitement des signes et symptômes de la maladie de Parkinson idiopathique, seule (sans lévodopa) ou en association avec la lévodopa,. au cours de la maladie, jusqu'à des stades tardifs où l'effet du lévodopa se dissipe ou devient inconstant et où des fluctuations de l'effet thérapeutique surviennent (fluctuations de fin de dose ou «on-off»). Mirapexin est indiqué pour le traitement symptomatique de la forme modérée à sévère idiopathique syndrome des jambes sans repos à des doses allant jusqu'à 0. 54 mg de base (0. 75 mg de sel).

Product summary:

Revision: 40

Authorization status:

Autorisé

Authorization date:

1998-02-23

Patient Information leaflet

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Summary of Product characteristics

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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 23-01-2024
Summary of Product characteristics Summary of Product characteristics Bulgarian 23-01-2024
Public Assessment Report Public Assessment Report Bulgarian 06-01-2011
Patient Information leaflet Patient Information leaflet Spanish 23-01-2024
Public Assessment Report Public Assessment Report Spanish 06-01-2011
Patient Information leaflet Patient Information leaflet Czech 23-01-2024
Public Assessment Report Public Assessment Report Czech 06-01-2011
Patient Information leaflet Patient Information leaflet Danish 23-01-2024
Public Assessment Report Public Assessment Report Danish 06-01-2011
Patient Information leaflet Patient Information leaflet German 23-01-2024
Public Assessment Report Public Assessment Report German 06-01-2011
Patient Information leaflet Patient Information leaflet Estonian 23-01-2024
Public Assessment Report Public Assessment Report Estonian 06-01-2011
Patient Information leaflet Patient Information leaflet Greek 23-01-2024
Public Assessment Report Public Assessment Report Greek 06-01-2011
Patient Information leaflet Patient Information leaflet English 23-01-2024
Public Assessment Report Public Assessment Report English 06-01-2011
Patient Information leaflet Patient Information leaflet Italian 23-01-2024
Public Assessment Report Public Assessment Report Italian 06-01-2011
Patient Information leaflet Patient Information leaflet Latvian 23-01-2024
Public Assessment Report Public Assessment Report Latvian 06-01-2011
Patient Information leaflet Patient Information leaflet Lithuanian 23-01-2024
Summary of Product characteristics Summary of Product characteristics Lithuanian 23-01-2024
Public Assessment Report Public Assessment Report Lithuanian 06-01-2011
Patient Information leaflet Patient Information leaflet Hungarian 23-01-2024
Summary of Product characteristics Summary of Product characteristics Hungarian 23-01-2024
Public Assessment Report Public Assessment Report Hungarian 06-01-2011
Patient Information leaflet Patient Information leaflet Maltese 23-01-2024
Public Assessment Report Public Assessment Report Maltese 06-01-2011
Patient Information leaflet Patient Information leaflet Dutch 23-01-2024
Public Assessment Report Public Assessment Report Dutch 06-01-2011
Patient Information leaflet Patient Information leaflet Polish 23-01-2024
Public Assessment Report Public Assessment Report Polish 06-01-2011
Patient Information leaflet Patient Information leaflet Portuguese 23-01-2024
Summary of Product characteristics Summary of Product characteristics Portuguese 23-01-2024
Public Assessment Report Public Assessment Report Portuguese 06-01-2011
Patient Information leaflet Patient Information leaflet Romanian 23-01-2024
Public Assessment Report Public Assessment Report Romanian 06-01-2011
Patient Information leaflet Patient Information leaflet Slovak 23-01-2024
Public Assessment Report Public Assessment Report Slovak 06-01-2011
Patient Information leaflet Patient Information leaflet Slovenian 23-01-2024
Summary of Product characteristics Summary of Product characteristics Slovenian 23-01-2024
Public Assessment Report Public Assessment Report Slovenian 06-01-2011
Patient Information leaflet Patient Information leaflet Finnish 23-01-2024
Public Assessment Report Public Assessment Report Finnish 06-01-2011
Patient Information leaflet Patient Information leaflet Swedish 23-01-2024
Public Assessment Report Public Assessment Report Swedish 06-01-2011
Patient Information leaflet Patient Information leaflet Norwegian 23-01-2024
Summary of Product characteristics Summary of Product characteristics Norwegian 23-01-2024
Patient Information leaflet Patient Information leaflet Icelandic 23-01-2024
Summary of Product characteristics Summary of Product characteristics Icelandic 23-01-2024
Patient Information leaflet Patient Information leaflet Croatian 23-01-2024

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