This is a summary of the European public assessment report (EPAR) for Sifrol. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sifrol.
Therapeutic Indication
### Therapeutic 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).
Therapeutic Area (MeSH)
ATC Code
N04BC05
ATC Item
pramipexole
Pharmacotherapeutic Group
Anti-Parkinson drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| pramipexole dihydrochloride monohydrate | N/A | 普拉克索 |
EMA Name
Sifrol
Medicine Name
Sifrol
Aliases
N/ANo risk management plan link.
