| Name |
Rispolept 4 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-410432880 |
| Active Substance |
risperidon |
| Composition |
jedna filmom obložena tableta sadrži 4 mg risperidona |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Janssen-Cilag S.p.A., Borgo San Michele, Latina, Italija |
| Marketing Authorisation Holder |
Johnson & Johnson S.E. d.o.o., Oreškovićeva 6h, Zagreb, Hrvatska |
| Marketing Authorisation Date |
29.11.2017 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/16-02/329 |
| Registration Number |
381-12-01/70-17-06 |
| 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 |
N05AX08 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
