Medicinal Products

Ambrisentan Teva 5 mg filmom obložene tablete

Name Ambrisentan Teva 5 mg filmom obložene tablete
Marketing Authorisation Number HR-H-739997107
Active Substance ambrisentan
Composition jedna tableta sadrži 5 mg ambrisentana
Pharmaceutical Form filmom obložena tableta
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
MA Revocation Date 11.04.2024*
Classification Number UP/I-530-09/18-01/115
Registration Number 381-12-01/70-20-03
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code C02KX02
Marketing status trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
Educational materials
for healthcare professionals
Kartica s podsjetnikom za bolesnike, verzija 2

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

Packaging

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