Medicinal Products

Erlotinib Sandoz 25 mg filmom obložene tablete

Name Erlotinib Sandoz 25 mg filmom obložene tablete
Marketing Authorisation Number HR-H-494615215
Active Substance erlotinibklorid
Composition svaka filmom obložena tableta sadrži 25 mg erlotiniba (u obliku erlotinibklorida)
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 30 tableta u blisteru, u kutiji  [HR-H-494615215-01]
Manufacturer Remedica Ltd., Limassol, Cipar
Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date 27.06.2017
MA Period of Validity 27.06.2022
MA Revocation Date 03.03.2022*
Classification Number UP/I-530-09/16-01/116
Registration Number 381-12-01/30-17-05
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

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Marketing authorisation has been revoked by request of the marketing authorisation holder.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

Back