| Name |
Rispolept 1 mg/ml oralna otopina |
| Former Name |
Rispolept 1 mg/ml otopina za oralnu primjenu |
| Marketing Authorisation Number |
HR-H-242934497 |
| Active Substance |
risperidon |
| Composition |
jedan ml oralne otopine sadrži 1 mg risperidona |
| Pharmaceutical Form |
oralna otopina |
| Manufacturer |
Janssen Pharmaceutica N.V., Beerse, Belgija |
| 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-530-09/16-02/325 |
| Registration Number |
381-12-01/70-17-06 |
| Prescription |
na recept |
| Type of prescription |
ponovljivi recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
N05AX08 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
