Medicinal Products

Erlotinib Actavis 100 mg filmom obložene tablete

Name Erlotinib Actavis 100 mg filmom obložene tablete
Marketing Authorisation Number HR-H-071602388
Active Substance erlotinibklorid
Composition jedna filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida)
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 30 tableta u blisteru, u kutiji  [HR-H-071602388-01]
Manufacturer S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska
Marketing Authorisation Holder Actavis Group PTC ehf., Reykjavikurvegur 76-78, Hafnarfjordur, Island
Marketing Authorisation Date 12.05.2017
MA Period of Validity 12.05.2022
MA Revocation Date 09.08.2021*
Classification Number UP/I-530-09/15-01/214
Registration Number 381-12-01/70-17-02
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01EB02
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Brošura za zdravstvene radnike, verzija 2


Marketing authorisation has been revoked by request of the marketing authorisation holder.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.