Sunitinib Pliva 50 mg tvrde kapsule
| Name | Sunitinib Pliva 50 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-838287566 |
| Active Substance | sunitinib |
| Composition | jedna kapsula sadrži 50 mg sunitiniba |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska
Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka Pliva Hrvatska d.o.o., Zagreb, Hrvatska Actavis International Ltd., Luqa, Malta Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.02.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/56 |
| Registration Number | 381-12-01/171-23-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01EX01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
