Produodopa 240 mg/ml + 12 mg/ml otopina za infuziju
Name | Produodopa 240 mg/ml + 12 mg/ml otopina za infuziju |
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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 |
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 | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | N04BA07 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |
Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 1 |