Medicinal Products

Phan 62,5 mg filmom obložene tablete

Name Phan 62,5 mg filmom obložene tablete
Marketing Authorisation Number HR-H-311046390
Active Substance bosentanum
Pharmaceutical Form filmom obložena tableta
Strength 62,5 mg
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 Pharmadox Healthcare Limited, Paola PLA, Malta;
Rontis Hellas S.A., Medical and Pharmaceutical Products, Larisa, Grčka
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb
Marketing Authorisation Date 30.11.2017
MA Period of Validity 30.11.2022
Classification Number UP/I-530-09/16-01/97
Registration Number 381-12-01/38-17-16
Composition jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku hidrata)
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
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