Bunalict 8 mg/2 mg sublingvalne tablete
| Name | Bunalict 8 mg/2 mg sublingvalne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-324019251 |
| Active Substance | buprenorfinklorid naloksonklorid dihidrat |
| Composition | svaka sublingvalna tableta sadrži 8 mg buprenorfina (u obliku klorida) i 2 mg naloksona (u obliku klorid dihidrata) |
| Pharmaceutical Form | sublingvalna tableta |
| Manufacturer | Ethypharm, Le Grand Quevilly, Francuska Ethypharm, Chateauneuf-en-Thymerais, Francuska Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 24.11.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/83 |
| Registration Number | 381-12-01/154-22-02 |
| 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 | N07BC51 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
