Pramipexole Teva (pramipexole)
- Region
- 🇪🇺 EU
- Active substance
- pramipexole
- Company
- Teva Pharma B.V.
- Status
- Authorised
- Therapeutic area
- Parkinson Disease
- CHMP opinion
- Thu 23 Oct 2008
- EU approval
- Thu 18 Dec 2008
- Designations
- Generic
- Application
- EMEA/H/C/000940
- ATC
- N04BC05
- Official record
- www.ema.europa.eu
Indication
Pramipexole Teva 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). Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mirapexin Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Sifrol Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 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- 🇪🇺 Pramipexole Accord Withdrawn · Accord Healthcare S.L.U.
- 🇪🇺 Daquiran Withdrawn · Dr.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.