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 |
Medicinal product subject to medical prescription |
Type of prescription |
ponovljivi recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
N05AX08 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |