Sifrol (pramipexole)
- Region
- 🇪🇺 EU
- Active substance
- pramipexole
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Restless Legs Syndrome; Parkinson Disease
- CHMP opinion
- Wed 18 Jun 1997
- EU approval
- Mon 13 Oct 1997
- Application
- EMEA/H/C/000133
- ATC
- N04BC05
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mirapexin 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- 🇪🇺 Pramipexole Accord Withdrawn · Accord Healthcare S.L.U.
- 🇪🇺 Daquiran Withdrawn · Dr.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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