| Name |
Rispolept Consta 50 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem |
| Marketing Authorisation Number |
HR-H-805764530 |
| Active Substance |
risperidon |
| Composition |
jedna bočica (=131,2 mg mikrosfere) sadrži 50 mg risperidona |
| 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-530-09/19-02/43 |
| Registration Number |
381-12-01/30-20-07 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| 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 |
