| Name |
OxyContin 20 mg tablete s produljenim oslobađanjem |
| Marketing Authorisation Number |
HR-H-188823708 |
| Active Substance |
oksikodonklorid |
| Composition |
jedna tableta s produljenim oslobađanjem sadrži 20 mg oksikodonklorida što odgovara 18 mg oksikodona |
| Pharmaceutical Form |
tableta s produljenim oslobađanjem |
| Manufacturer |
Mundipharma DC B.V., Leusden, Nizozemska |
| Marketing Authorisation Holder |
Mundipharma Gesellschaft m.b.H., Wiedner Gurtel 13, Turm 24, OG 15, Beč, Austrija |
| Marketing Authorisation Date |
13.09.2016 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/16-02/234 |
| Registration Number |
381-12-01/70-16-03 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to special medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N02AA05 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
