Amlodipin/valsartan Sandoz 5 mg/80 mg filmom obložene tablete
| Name | Amlodipin/valsartan Sandoz 5 mg/80 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-616802393 |
| 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-616802393-01] 14 tableta u blisteru, u kutiji [HR-H-616802393-02] 28 tableta u blisteru, u kutiji [HR-H-616802393-03] 30 tableta u blisteru, u kutiji [HR-H-616802393-04] 56 tableta u blisteru, u kutiji [HR-H-616802393-05] 90 tableta u blisteru, u kutiji [HR-H-616802393-06] 98 tableta u blisteru, u kutiji [HR-H-616802393-07] 280 tableta u blisteru, u kutiji [HR-H-616802393-08] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-616802393-09] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-616802393-10] 280 tableta u blisteru s jediničnom dozom,u, u kutiji [HR-H-616802393-11] 280 tableta (višestruko pakiranje od 4 kutije, od kojih svaka sadrži 70 tableta), u kutiji [HR-H-616802393-12] 280 tableta (višestruko pakiranje od 20 kutija, od kojih svaka sadrži 14 tableta), u kutiji [HR-H-616802393-13] |
| 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 | 12.10.2021 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 07.08.2023* |
| Classification Number | UP/I-530-09/20-02/76 |
| Registration Number | 381-12-01/30-21-05 |
| 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 | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
