Lefisyo 5 mg/ml oralna otopina
| Name | Lefisyo 5 mg/ml oralna otopina |
|---|---|
| Marketing Authorisation Number | HR-H-235131722 |
| Active Substance | levometadonklorid |
| Composition | jedan ml oralne otopine sadrži 5 mg levometadonklorida (što odgovara 4,47 mg levometadona) |
| Pharmaceutical Form | Oralna otopina |
| Manufacturer | Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Holder | Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Date | 18.03.2022 |
| MA Period of Validity | 18.03.2027 |
| Classification Number | UP/I-530-09/21-01/59 |
| Registration Number | 381-12-01/154-22-03 |
| Prescription | na recept |
| Type of prescription | poseban recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N07BC05 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
