Erlotinib Actavis 25 mg filmom obložene tablete
Name | Erlotinib Actavis 25 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-382619837 |
Active Substance | erlotinibum |
Pharmaceutical Form | filmom obložena tableta |
Strength | 25 mg |
Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-382619837-01] |
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 |
Classification Number | UP/I-530-09/15-01/213 |
Registration Number | 381-12-01/70-17-04 |
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 |