Phan 62,5 mg filmom obložene tablete
Name | Phan 62,5 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-311046390 |
Active Substance | bosentan hidrat |
Composition | jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku hidrata) |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 14 tableta u blisteru, u kutiji [HR-H-311046390-01] 56 tableta u blisteru, u kutiji [HR-H-311046390-02] 112 tableta u blisteru, u kutiji [HR-H-311046390-03] |
Manufacturer | Rontis Hellas Medical and Pharmaceutical Products S.A., Larisa, Grčka |
Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
Marketing Authorisation Date | 01.12.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/24 |
Registration Number | 381-12-01/70-22-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C02KX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | preuzmi |
Educational materials for patients / caregivers |
Knjižica za bolesnika s važnim uputama za sigurnu primjenu lijeka, verzija 2 |