Bosentan Makpharm 62,5 mg filmom obložene tablete
Name | Bosentan Makpharm 62,5 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-210843347 |
Active Substance | bosentan hidrat |
Composition | jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata) |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 14 tableta u blisteru, u kutiji [HR-H-210843347-01] 56 tableta u blisteru, u kutiji [HR-H-210843347-02] 112 tableta u blisteru, u kutiji [HR-H-210843347-03] |
Manufacturer | Pharmascience International Limited, Nicosia, Cipar
GE Pharmaceuticals Ltd., Botevgrad, Bugarska |
Marketing Authorisation Holder | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
Marketing Authorisation Date | 24.01.2020 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/19-02/229 |
Registration Number | 381-12-01/30-20-03 |
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 | Nestašica |
SmPC | download |
PL | download |
Public Assessment Report | download |
Educational materials for patients / caregivers |
Knjižica za bolesnika s važnim uputama za sigurnu primjenu lijeka, verzija 2 |