Rozor 20 mg/10 mg filmom obložene tablete
| Name | Rozor 20 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-978548703 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | Jedna filmom obložena tableta sadrži 20 mg rosuvastatina (u obliku kalcija) i 10 mg ezetimiba |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-978548703-01] 30 tableta u blisteru, u kutiji [HR-H-978548703-02] 60 tableta u blisteru, u kutiji [HR-H-978548703-03] 90 tableta u blisteru, u kutiji [HR-H-978548703-04] |
| Manufacturer | Pharmadox Healthcare Limited, Paola PLA, Malta
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Irska Mylan Hungary Kft, Komárom, Mađarska |
| Marketing Authorisation Holder | Mylan Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska |
| Marketing Authorisation Date | 08.12.2022 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 16.02.2023* |
| Classification Number | UP/I-530-09/21-02/129 |
| Registration Number | 381-12-01/38-22-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BA06 |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
