Lefisyo 5 mg/ml oralna otopina
Name | Lefisyo 5 mg/ml oralna otopina |
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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 |