Onelar 60 mg tvrde želučanootporne kapsule
| Name | Onelar 60 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-423739312 |
| Active Substance | duloksetinklorid |
| Composition | jedna kapsula sadrži 60 mg duloksetina (u obliku klorida) |
| Pharmaceutical Form | želučanootporna kapsula, tvrda |
| Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-423739312-01] 28 kapsula u blisteru, u kutiji [HR-H-423739312-02] 30 kapsula u blisteru, u kutiji [HR-H-423739312-03] 56 kapsula u blisteru, u kutiji [HR-H-423739312-04] 84 kapsule u blisteru, u kutiji [HR-H-423739312-05] 98 kapsula u blisteru, u kutiji [HR-H-423739312-06] 100 kapsula u blisteru, u kutiji [HR-H-423739312-07] 140 kapsula u blisteru, u kutiji [HR-H-423739312-08] 196 kapsula u blisteru, u kutiji [HR-H-423739312-09] 500 kapsula u blisteru, u kutiji [HR-H-423739312-10] |
| Manufacturer | Medochemie Ltd., Limassol, Cipar |
| Marketing Authorisation Holder | Medochemie Ltd., Constatinoupoleos Str. 1-10, Limassol, Cipar |
| Marketing Authorisation Date | 07.08.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/58 |
| Registration Number | 381-12-01/38-20-02 |
| 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 |
