Duloksetin Pliva 60 mg želučanootporne tvrde kapsule
| Name | Duloksetin Pliva 60 mg želučanootporne tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-406299508 |
| Active Substance | duloksetinklorid |
| Composition | svaka kapsula sadrži duloksetinklorid koji odgovara 60 mg duloksetina |
| Pharmaceutical Form | želučanootporna kapsula, tvrda |
| Packaging [MA Number for Packaging] | 100 kapsula u bočici, u kutiji [HR-H-406299508-01] 14 kapsula u blisteru, u kutiji [HR-H-406299508-02] 28 kapsula u blisteru, u kutiji [HR-H-406299508-03] 30 kapsula u blisteru, u kutiji [HR-H-406299508-04] 56 kapsula u blisteru, u kutiji [HR-H-406299508-05] 98 kapsula u blisteru, u kutiji [HR-H-406299508-06] 100 kapsula u blisteru, u kutiji [HR-H-406299508-07] |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 11.12.2019 |
| MA Period of Validity | 11.12.2024 |
| Classification Number | UP/I-530-09/18-01/211 |
| Registration Number | 381-12-01/70-19-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N06AX21 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
