Darunavir Sandoz 800 mg filmom obložene tablete
Name | Darunavir Sandoz 800 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-359833569 |
Active Substance | darunavir |
Composition | svaka filmom obložena tableta sadrži 800 mg darunavira |
Pharmaceutical Form | filmom obložena tableta |
Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija Remedica Ltd., Limassol, Cipar Salutas Pharma GmbH, Barleben, Njemačka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 07.03.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/62 |
Registration Number | 381-12-01/154-22-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J05AE10 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |