Oksikodon/nalokson Pliva 10 mg/5 mg tablete s produljenim oslobađanjem
| Name | Oksikodon/nalokson Pliva 10 mg/5 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-259438671 |
| Active Substance | oksikodonklorid naloksonklorid dihidrat |
| Composition | jedna tableta s produljenim oslobađanjem sadrži 10 mg oksikodonklorida (što odgovara 9 mg oksikodona) i 5 mg naloksonklorida (u obliku 5,45 mg naloksonklorid dihidrata što odgovara 4,5 mg naloksona) |
| Pharmaceutical Form | tableta s produljenim oslobađanjem |
| Manufacturer | Develco Pharma GmbH, Schopfheim, Njemačka
Teva Operations Poland Sp. z o.o., Krakow, Poljska Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 15.05.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/32 |
| Registration Number | 381-12-01/70-20-02 |
| Prescription | na recept |
| Type of prescription | poseban recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N02AA55 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
