Aprepitant Alpha-Medical 125 mg + 80 mg tvrde kapsule
| Name | Aprepitant Alpha-Medical 125 mg + 80 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-359140886 |
| Active Substance | aprepitant |
| Composition | jedna kapsula sadrži 125 mg aprepitanta jedna kapsula sadrži 80 mg aprepitanta |
| Pharmaceutical Form | kapsula, tvrda |
| Packaging [MA Number for Packaging] | 1 kapsula od 125 mg i 2 kapsule od 80 mg u džepnom blisteru s kartonskim pojačanjem, u kutiji [HR-H-359140886-01] |
| Manufacturer | Pharmathen International S.A., Rodopi, Grčka
Pharmathen S.A., Pallini, Grčka |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 30.04.2020 |
| MA Period of Validity | 30.04.2025 |
| Classification Number | UP/I-530-09/19-01/45 |
| Registration Number | 381-12-01/70-20-08 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | A04AD12 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
