Abirateron Teva 500 mg filmom obložene tablete
| Name | Abirateron Teva 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-944992831 |
| Active Substance | abirateronacetat |
| Composition | svaka filmom obložena tableta sadrži 500 mg abirateronacetata, što odgovara 446,3 mg abiraterona |
| Pharmaceutical Form | Filmom obložena tableta |
| Packaging [MA Number for Packaging] | 14 tableta u blisteru, u kutiji [HR-H-944992831-01] 56 tableta u blisteru, u kutiji [HR-H-944992831-02] 60 tableta u blisteru, u kutiji [HR-H-944992831-03] 120 tableta u blisteru, u kutiji [HR-H-944992831-04] 14 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-944992831-05] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-944992831-06] 60 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-944992831-07] 120 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-944992831-08] |
| Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Ulm, Njemačka Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 09.05.2022 |
| MA Period of Validity | 09.05.2027 |
| Classification Number | UP/I-530-09/20-01/267 |
| Registration Number | 381-12-01/70-22-05 |
| 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 |
