Dipperam 5 mg/80 mg filmom obložene tablete
| Name | Dipperam 5 mg/80 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-088017946 |
| Active Substance | amlodipinbesilat valsartan |
| Composition | svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 80 mg valsartana |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 7 tableta u blisteru, u kutiji [HR-H-088017946-01] 14 tableta u blisteru, u kutiji [HR-H-088017946-02] 28 tableta u blisteru, u kutiji [HR-H-088017946-03] 30 tableta u blisteru, u kutiji [HR-H-088017946-04] 56 tableta u blisteru, u kutiji [HR-H-088017946-05] 90 tableta u blisteru, u kutiji [HR-H-088017946-06] 98 tableta u blisteru, u kutiji [HR-H-088017946-07] 280 tableta u blisteru, u kutiji [HR-H-088017946-08] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-088017946-09] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-088017946-10] 280 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-088017946-11] 280 tableta (20 pakiranja sa po 14 tableta u blisteru), u kutiji [HR-H-088017946-12] 280 tableta (4 pakiranja sa po 70 tableta u blisteru), u kutiji [HR-H-088017946-13] |
| 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-530-09/21-02/151 |
| Registration Number | 381-12-01/70-22-03 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C09DB01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
