| Name |
Palexia 20 mg/ml oralna otopina |
| Marketing Authorisation Number |
HR-H-173293107 |
| Active Substance |
tapentadolklorid |
| Composition |
1 ml oralne otopine sadrži 20 mg tapentadola (u obliku tapentadolklorida) |
| Pharmaceutical Form |
oralna otopina |
| Manufacturer |
Grünenthal GmbH, Aachen, Njemačka |
| Marketing Authorisation Holder |
Grünenthal GmbH, Zieglerstraße 6, Aachen, Njemačka |
| Marketing Authorisation Date |
27.07.2015 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/14-02/422 |
| Registration Number |
381-12-01/30-15-07 |
| 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 |
N02AX06 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
