Rispolept 1 mg/ml oralna otopina
| 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 Lusomedicamenta-Sociedade Tecnica Farmaceutica, SA, Barcarena, Portugal |
| 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 | 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 |
