| Name |
Transtec 52,5 mikrogram/h transdermalni flaster |
| Marketing Authorisation Number |
HR-H-906948213 |
| Active Substance |
buprenorfin |
| Composition |
jedan transdermalni flaster sadrži 30 mg buprenorfina
dodirna površina koja sadrži djelatnu tvar: 37,5 cm2
nominalna brzina oslobađanja: 52,5 µg buprenorfina na sat (tijekom 96 sati)
|
| Pharmaceutical Form |
transdermalni flaster |
| Manufacturer |
Grünenthal GmbH, Aachen, Njemačka |
| Marketing Authorisation Holder |
STADA Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel, Njemačka |
| Marketing Authorisation Date |
23.01.2026 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/15-02/23 |
| Registration Number |
381-12-01/171-26-34 |
| 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 |
N02AE01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |