Abirateron Sandoz 500 mg filmom obložene tablete
Name | Abirateron Sandoz 500 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-328523636 |
Active Substance | abirateronacetat |
Composition | svaka filmom obložena tableta sadrži 500 mg abirateronacetata |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 56 tableta u blisteru, u kutiji [HR-H-328523636-01] 60 tableta u blisteru, u kutiji [HR-H-328523636-02] 84 tablete u blisteru, u kutiji [HR-H-328523636-03] 112 tablete u blisteru, u kutiji [HR-H-328523636-04] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-328523636-05] 60 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-328523636-06] 84 tablete u blisteru s jediničnom dozom, u kutiji [HR-H-328523636-07] 112 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-328523636-08] 60 tableta u bočici, u kutiji [HR-H-328523636-09] |
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 | 01.07.2021 |
MA Period of Validity | 01.07.2026 |
Classification Number | UP/I-530-09/19-01/272 |
Registration Number | 381-12-01/154-21-02 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L02BX03 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |