Medicinal Products

Bosentan Makpharm 125 mg filmom obložene tablete

Name Bosentan Makpharm 125 mg filmom obložene tablete
Marketing Authorisation Number HR-H-476813490
Active Substance bosentanum
Pharmaceutical Form filmom obložena tableta
Strength 125 mg
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
Marketing Authorisation Holder Makpharm d.o.o., Folnegovićeva 1/A, 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
Composition jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan 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 download
Educational materials
for patients / caregivers
Knjižica za bolesnika s važnim uputama za sigurnu primjenu lijeka, verzija 2
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