Dipperam HCT 5 mg/160 mg/25 mg filmom obložene tablete
Name | Dipperam HCT 5 mg/160 mg/25 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-731274101 |
Active Substance | amlodipinbesilat valsartan hidroklorotiazid |
Composition | svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida |
Pharmaceutical Form | filmom obložena tableta |
Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka
Novartis Pharma GmbH, Nürnberg, Njemačka Novartis Farma S.p.A., Torre Annunziata (Napulj), Italija Novartis Farmacéutica S.A., Barcelona, Španjolska |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 26.10.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/140 |
Registration Number | 381-12-01/70-23-03 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C09DX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |