Runaplax 10 mg filmom obložene tablete
Name | Runaplax 10 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-510587260 |
Active Substance | rivaroksaban |
Composition | svaka filmom obložena tableta sadrži 10 mg rivaroksabana |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 5 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-510587260-01] 10 tableta u blisteru, u kutiji [HR-H-510587260-02] 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-510587260-03] 14 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-510587260-04] 20 tableta u blisteru, u kutiji [HR-H-510587260-05] 28 tableta u blisteru, u kutiji [HR-H-510587260-06] 30 tableta u blisteru, u kutiji [HR-H-510587260-07] 42 tablete u blisteru, u kutiji [HR-H-510587260-08] 50 tableta u blisteru, u kutiji [HR-H-510587260-09] 98 tableta u blisteru, u kutiji [HR-H-510587260-10] 100 tableta u blisteru, u kutiji [HR-H-510587260-11] 100 tableta u bočici, u kutiji [HR-H-510587260-12] 5 tableta u blisteru, u kutiji [HR-H-510587260-13] 7 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-510587260-14] |
Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 10.10.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/192 |
Registration Number | 381-12-01/154-22-04 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B01AF01 |
Medicinal product marketed in the Croatia | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |
Educational materials for healthcare professionals |
Vodič za liječnike s informacijama o primjeni rivaroksabana, verzija 1 |
Educational materials for patients / caregivers |
Kartica s upozorenjima za bolesnika Runaplax |