Bosentan Makpharm 125 mg filmom obložene tablete
| Name | Bosentan Makpharm 125 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-476813490 |
| Active Substance | bosentan hidrat |
| Composition | jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata) |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 56 tableta u blisteru, u kutiji [HR-H-476813490-01] 112 tableta u blisteru, u kutiji [HR-H-476813490-02] |
| 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-530-09/19-02/230 |
| Registration Number | 381-12-01/30-20-02 |
| 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 |
