Lapatinib Teva 250 mg filmom obložene tablete
Name | Lapatinib Teva 250 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-575193071 |
Active Substance | lapatinibditosilat hidrat |
Composition | jedna filmom obložena tableta sadrži lapatinibditosilat hidrat, što odgovara 250 mg lapatiniba |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Actavis Group PTC ehf., Hafnarfjoerdur, Island
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska Actavis International Ltd., Luqa, Malta |
Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Str. 3, Ulm, Njemačka |
Marketing Authorisation Date | 17.08.2023 |
MA Period of Validity | 17.08.2028 |
Classification Number | UP/I-530-09/21-01/308 |
Registration Number | 381-12-01/171-23-08 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01EH01 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |