Ocaliva
The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
Name | Ocaliva |
---|---|
Active Substance | obetikolatna kiselina |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
ATC Code | A05AA04 |
Medicinal product marketed in the Croatia | Da |
Summary of product characteristics (SmPC), labelling and package leaflet (PL) | download |
Link to the European Medicines Agency's (EMA) product information | download |
Link to the European Commission's (EC) decisions | download |
Direct Healthcare Professional Communication
Name | Date | Download |
---|---|---|
Pismo zdravstvenim radnicima o novoj kontraindikaciji lijeka Ocaliva (obetikolatna kiselina) za liječenje primarnog bilijarnog kolangitisa (PBK) u bolesnika s dekompenziranom cirozom jetre ili ranijom epizodom dekompenzacije jetre u anamnezi | 09.06.2022 | Intercept Pharma International Ltd. |
Pismo zdravstvenim radnicima o preporukama za diferencijalno doziranje lijeka Ocaliva (obetikolatna kiselina) | 08.02.2018 | Intercept Pharma Ltd |