Aripiprazol Pliva 10 mg tablete
| Name | Aripiprazol Pliva 10 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-532398568 |
| Active Substance | aripiprazol |
| Composition | svaka tableta sadrži 10 mg aripiprazola |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 7 tableta u blisteru, u kutiji [HR-H-532398568-01] 14 tableta u blisteru, u kutiji [HR-H-532398568-02] 28 tableta u blisteru, u kutiji [HR-H-532398568-03] 30 tableta u blisteru, u kutiji [HR-H-532398568-04] 49 tableta u blisteru, u kutiji [HR-H-532398568-05] 56 tableta u blisteru, u kutiji [HR-H-532398568-06] 60 tableta u blisteru, u kutiji [HR-H-532398568-07] 98 tableta u blisteru, u kutiji [HR-H-532398568-08] 100 tableta u blisteru, u kutiji [HR-H-532398568-09] 7 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-532398568-10] 14 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-532398568-11] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-532398568-12] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-532398568-13] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-532398568-14] 100 tableta u bočici, u kutiji [HR-H-532398568-15] |
| Manufacturer | Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka
Teva Pharma B.V., Haarlem, Nizozemska Pliva Hrvatska d.o.o., Zagreb, Hrvatska Teva Operations Poland Sp. z o.o., Krakow, Poljska Actavis Limited, Zejtun, Malta PharmaPath S.A., Agia, Varvara, Grčka |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 08.05.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/05 |
| Registration Number | 381-12-01/30-19-03 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N05AX12 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
