Emtricitabin/tenofovirdizoproksil Remedica 200 mg/245 mg filmom obložene tablete
Name | Emtricitabin/tenofovirdizoproksil Remedica 200 mg/245 mg filmom obložene tablete |
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Former Name | Emtricitabin/tenofovirdizoproksil Alpha-Medical 200 mg/245 mg filmom obložene tablete |
Marketing Authorisation Number | HR-H-279516622 |
Active Substance | emtricitabin tenofovirdizoproksilsukcinat |
Composition | jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilsukcinata) |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 30 tableta u bočici, u kutiji [HR-H-279516622-01] 90 tableta (30 tableta u bočici u kutiji, 3 kutije omotane prozirnom folijom) [HR-H-279516622-02] |
Manufacturer | Remedica Ltd., Limassol, Cipar |
Marketing Authorisation Holder | Remedica Ltd., Aharnon Street, Limassol Industrial Estate, Limassol, Cipar |
Marketing Authorisation Date | 03.03.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/87 |
Registration Number | 381-12-01/38-22-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J05AR03 |
Medicinal product marketed in the Croatia | Privremeni prekid opskrbe |
SmPC | download |
PL | download |
Public Assessment Report | download |