Olandix 10 mg raspadljive tablete za usta
| Name | Olandix 10 mg raspadljive tablete za usta |
|---|---|
| Marketing Authorisation Number | HR-H-560052499 |
| Active Substance | olanzapin |
| Composition | jedna raspadljiva tableta za usta sadrži 10 mg olanzapina |
| Pharmaceutical Form | raspadljiva tableta za usta |
| Packaging [MA Number for Packaging] | 28 tableta u blisteru, u kutiji [HR-H-560052499-01] |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska Teva Pharma S.L.U., Zaragoza, Španjolska Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka Teva Pharma B.V., Haarlem, Nizozemska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 21.05.2015 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/452 |
| Registration Number | 381-12-01/30-15-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N05AH03 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
