Produodopa 240 mg/ml + 12 mg/ml otopina za infuziju
| Name | Produodopa 240 mg/ml + 12 mg/ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-382772882 |
| Active Substance | foslevodopa foskarbidopa |
| Composition | 1 ml otopine sadrži 240 mg foslevodope (što odgovara približno 170 mg levodope) i 12 mg foskarbidope (što odgovara približno 9 mg karbidope) 10 ml otopine sadrži 2400 mg foslevodope (što odgovara približno 1700 mg levodope) i 120 mg foskarbidope (što odgovara približno 90 mg karbidope) |
| Pharmaceutical Form | Otopina za infuziju |
| Packaging [MA Number for Packaging] | 7 bočica sa 10 ml otopine, u kutiji [HR-H-382772882-01] |
| Manufacturer | AbbVie S.r.L., Campoverde di Aprilia (LT), Italija |
| Marketing Authorisation Holder | AbbVie d.o.o., Strojarska cesta 20, Zagreb, Hrvatska |
| Marketing Authorisation Date | 21.09.2022 |
| MA Period of Validity | 21.09.2027 |
| Classification Number | UP/I-530-09/21-01/183 |
| Registration Number | 381-12-01/70-22-08 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N04BA07 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 1 |
