Tivlemaq 10 mg, 20 mg i 30 mg filmom obložene tablete
Name | Tivlemaq 10 mg, 20 mg i 30 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-310635631 |
Active Substance | apremilast |
Composition | svaka filmom obložena tableta sadrži 10 mg apremilasta svaka filmom obložena tableta sadrži 20 mg apremilasta svaka filmom obložena tableta sadrži 30 mg apremilasta |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 13.05.2024 |
MA Period of Validity | 13.05.2029 |
Classification Number | UP/I-530-09/23-01/31 |
Registration Number | 381-12-01/171-24-08 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L04AA32 |
SmPC | download |
PL | download |
Public Assessment Report | download |