Targinact 10 mg/5 mg tablete s produljenim oslobađanjem
| Name | Targinact 10 mg/5 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-347037202 |
| Active Substance | oksikodonklorid naloksonklorid dihidrat |
| Composition | jedna tableta s produljenim oslobađanjem sadrži 10 mg oksikodonklorida, što odgovara 9,0 mg oksikodona, 5,45 mg naloksonklorid dihidrata, što odgovara 5,0 mg naloksonklorida i 4,5 mg naloksona |
| Pharmaceutical Form | tableta s produljenim oslobađanjem |
| 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 | 04.02.2016 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/428 |
| Registration Number | 381-12-01/30-16-04 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | poseban recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N02AA55 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
