Dipperam 5 mg/160 mg filmom obložene tablete
Name | Dipperam 5 mg/160 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-273437554 |
Active Substance | amlodipinbesilat valsartan |
Composition | svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 160 mg valsartana |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 7 tableta u blisteru, u kutiji [HR-H-273437554-01] 14 tableta u blisteru, u kutiji [HR-H-273437554-02] 28 tableta u blisteru, u kutiji [HR-H-273437554-03] 30 tableta u blisteru, u kutiji [HR-H-273437554-04] 56 tableta u blisteru, u kutiji [HR-H-273437554-05] 90 tableta u blisteru, u kutiji [HR-H-273437554-06] 98 tableta u blisteru, u kutiji [HR-H-273437554-07] 280 tableta u blisteru, u kutiji [HR-H-273437554-08] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-273437554-09] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-273437554-10] 280 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-273437554-11] 280 tableta (20 pakiranja sa po 14 tableta u blisteru), u kutiji [HR-H-273437554-12] 280 tableta (4 pakiranja sa po 70 tableta u blisteru), u kutiji [HR-H-273437554-13] |
Manufacturer | 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 | 14.06.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/152 |
Registration Number | 381-12-01/70-22-02 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C09DB01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |