Epri 5 mg filmom obložene tablete
| Name | Epri 5 mg filmom obložene tablete |
|---|---|
| Former Name | Rosuvastatin Pliva 5 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-022331335 |
| Active Substance | rosuvastatinkalcij |
| Composition | jedna tableta sadrži 5 mg rosuvastatina (u obliku rosuvastatinkalcija) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Merckle GmbH, Blaubeuren, Njemačka Pliva Hrvatska d.o.o., Zagreb, Hrvatska HBM Pharma s.r.o., Martin, Slovačka Teva Pharma B.V., Haarlem, Nizozemska Teva Pharma S.L.U., Zaragoza, Španjolska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 12.06.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/24 |
| Registration Number | 381-12-01/154-23-49 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10AA07 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
