Anpheros Search · Treatment

Pramipexole

Also known as: Sifrol · Mirapexin · Oprymea · Pramipexole Teva

General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).

In short

In the European Union, pramipexole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease, either alone or in combination with levodopa, including late stages when the effect of levodopa wears off or becomes inconsistent. In the European Union, it is also indicated for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base. In the United States, pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

From: Source: European Medicines Agency (EMA), Mirapexin — EPAR, 29/06/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Sifrol — EPAR, 30/06/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
746741 pramipexole
EMA
EMEA/H/C/000133, EMEA/H/C/000134, EMEA/H/C/000941, EMEA/H/C/000940

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Mirapexin

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).

Source: European Medicines Agency (EMA), Mirapexin — EPAR, 29/06/2026. © European Medicines Agency.

Document date: 29/06/2026 · Official document →

FDA (USA) PRAMIPEXOLE

1 INDICATIONS & USAGE PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist indicated for the treatment of • the signs and symptoms of idiopathic Parkinson's disease (PD) ( 1.1 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

Data provided by the U.S. Food and Drug Administration.

Document date: 20161013 · Official document →

EMA (EU) Sifrol

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).

Source: European Medicines Agency (EMA), Sifrol — EPAR, 30/06/2026. © European Medicines Agency.

Document date: 30/06/2026 · Official document →

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External resources

Questions

What is Pramipexole approved for in the European Union?

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). (Source: European Medicines Agency (EMA), Mirapexin — EPAR, 29/06/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Mirapexin — EPAR, 29/06/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Sifrol — EPAR, 30/06/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →