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 | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | A05AA04 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o preporuci za ukidanje odobrenja za stavljanje u promet u Europskoj uniji za lijek Ocaliva (obetikolatna kiselina) zbog nepotvrđene kliničke koristi | 31.07.2024 | ADVANZ PHARMA Limited |
| 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 |
