Oksikodon/nalokson Pliva 40 mg/20 mg tablete s produljenim oslobađanjem
Name | Oksikodon/nalokson Pliva 40 mg/20 mg tablete s produljenim oslobađanjem |
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Marketing Authorisation Number | HR-H-392541236 |
Active Substance | oksikodonklorid naloksonklorid dihidrat |
Composition | jedna tableta s produljenim oslobađanjem sadrži 40 mg oksikodonklorida (što odgovara 36 mg oksikodona) i 20 mg naloksonklorida (u obliku 21,8 mg naloksonklorid dihidrata što odgovara 18 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-530-09/20-02/35 |
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 |