Ribas 2,5 mg filmom obložene tablete
Name | Ribas 2,5 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-842325807 |
Active Substance | rivaroksaban |
Composition | jedna filmom obložena tableta sadrži 2,5 mg rivaroksabana |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-842325807-01] 60 tableta u blisteru, u kutiji [HR-H-842325807-02] |
Manufacturer | Genepharm S.A., Pallini, Attiki, Grčka
Pharmadox Healthcare Limited, Paola, Malta Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
Marketing Authorisation Date | 16.11.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/111 |
Registration Number | 381-12-01/171-23-03 |
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 | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | 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 Ribas |