Medicinal Products

Erlotinib Pliva 25 mg filmom obložene tablete

Name Erlotinib Pliva 25 mg filmom obložene tablete
Marketing Authorisation Number HR-H-466002854
Active Substance erlotinibum
Pharmaceutical Form filmom obložena tableta
Strength 25 mg
Packaging [MA Number for Packaging] 30 tableta u blisteru, u kutiji  [HR-H-466002854-01]
30 tableta u perforiranom blisteru, u kutiji  [HR-H-466002854-02]
Manufacturer Teva UK Ltd., East Sussex, Ujedinjeno Kraljevstvo;
Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska;
Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka;
Teva Gyogyszergyar Zrt., Debrecen, Mađarska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb
Marketing Authorisation Date 12.12.2016
MA Period of Validity 12.12.2021
MA Revocation Date 30.05.2019*
Classification Number UP/I-530-09/15-01/201
Registration Number 381-12-01/38-16-10
Composition jedna filmom obložena tableta sadrži 25 mg erlotiniba (u obliku erlotinibklorida)
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01XE03
Medicinal product marketed in the Croatia Ne
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Brošura za zdravstvene radnike, 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

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