| Name |
Pramipeksol Pliva 2,1 mg tablete s produljenim oslobađanjem |
| Marketing Authorisation Number |
HR-H-721339949 |
| Active Substance |
pramipeksoldiklorid hidrat |
| Composition |
jedna tableta s produljenim oslobađanjem sadrži 3 mg pramipeksoldiklorid hidrata što odgovara 2,1 mg pramipeksola |
| Pharmaceutical Form |
tableta s produljenim oslobađanjem |
| Manufacturer |
Laboratorios Normon S.A., Tres Cantos – Madrid, Španjolska |
| Marketing Authorisation Holder |
Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date |
03.12.2019 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/56 |
| Registration Number |
381-12-01/30-19-02 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N04BC05 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
