Mirapexin (pramipexole)
- Region
- 🇪🇺 EU
- Active substance
- pramipexole
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Restless Legs Syndrome; Parkinson Disease
- EU approval
- Mon 23 Feb 1998
- Application
- EMEA/H/C/000134
- ATC
- N04BC05
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sifrol Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Pramipexole Teva Authorised · Teva Pharma B.V.
- 🇪🇺 Oprymea Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Pramipexole Accord Withdrawn · Accord Healthcare S.L.U.
- 🇪🇺 Daquiran Withdrawn · Dr. Karl Thomae GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.