OxyContin 10 mg tablete s produljenim oslobađanjem
Name | OxyContin 10 mg tablete s produljenim oslobađanjem |
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Marketing Authorisation Number | HR-H-118192252 |
Active Substance | oksikodonklorid |
Composition | jedna tableta s produljenim oslobađanjem sadrži 10 mg oksikodonklorida što odgovara 9,0 mg oksikodona |
Pharmaceutical Form | tableta s produljenim oslobađanjem |
Packaging [MA Number for Packaging] | 20 tableta u blisteru, u kutiji [HR-H-118192252-01] 30 tableta u blisteru, u kutiji [HR-H-118192252-02] 50 tableta u blisteru, u kutiji [HR-H-118192252-03] 60 tableta u blisteru, u kutiji [HR-H-118192252-04] 100 tableta u blisteru, u kutiji [HR-H-118192252-05] 100 tableta u blisteru, u kutiji (bolničko pakiranje) [HR-H-118192252-06] |
Manufacturer | Fidelio Healthcare Limburg GmbH, Limburg, Njemačka 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-530-09/16-02/233 |
Registration Number | 381-12-01/70-16-05 |
Prescription | na recept |
Type of prescription | poseban recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N02AA05 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |