Medicinal Products

Ambrisentan Teva 10 mg filmom obložene tablete

Name Ambrisentan Teva 10 mg filmom obložene tablete
Marketing Authorisation Number HR-H-271635310
Active Substance ambrisentan
Composition jedna tableta sadrži 10 mg ambrisentana
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 10 tableta u blisteru, u kutiji  [HR-H-271635310-01]
30 tableta u blisteru, u kutiji  [HR-H-271635310-02]
60 tableta u blisteru, u kutiji  [HR-H-271635310-03]
120 tableta u blisteru, u kutiji  [HR-H-271635310-04]
10 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-271635310-05]
30 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-271635310-06]
60 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-271635310-07]
120 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-271635310-08]
Manufacturer Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
Marketing Authorisation Holder Teva B.V., Swensweg 5, Haarlem, Nizozemska
Marketing Authorisation Date 10.02.2020
MA Period of Validity 10.02.2025
Classification Number UP/I-530-09/18-01/116
Registration Number 381-12-01/70-20-02
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code C02KX02
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
Educational materials
for patients / caregivers
Kartica s podsjetnikom za bolesnike, verzija 2
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