Name |
Rispolept Consta 25 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem |
Marketing Authorisation Number |
HR-H-137353036 |
Active Substance |
risperidon |
Composition |
jedna bočica (=65,6 mg mikrosfere) sadrži 25 mg risperidon |
Pharmaceutical Form |
prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem |
Manufacturer |
Janssen Pharmaceutica N.V., Beerse, Belgija |
Marketing Authorisation Holder |
Johnson & Johnson S.E. d.o.o., Oreškovićeva 6h, Zagreb, Hrvatska |
Marketing Authorisation Date |
30.09.2020 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/19-02/41 |
Registration Number |
381-12-01/30-20-08 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
N05AX08 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |