Bupensanduo 4 mg/1 mg sublingvalne tablete
| Name | Bupensanduo 4 mg/1 mg sublingvalne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-125576373 |
| Active Substance | buprenorfinklorid naloksonklorid dihidrat |
| Composition | svaka sublingvalna tableta sadrži 4 mg buprenorfina (u obliku klorida) i 1 mg naloksona (u obliku klorid dihidrata). |
| Pharmaceutical Form | sublingvalna tableta |
| Packaging [MA Number for Packaging] | 7 tableta u blisteru, u kutiji [HR-H-125576373-01] 28 tableta u blisteru, u kutiji [HR-H-125576373-02] 49 tableta u blisteru, u kutiji [HR-H-125576373-03] 56 tableta u blisteru, u kutiji [HR-H-125576373-04] 7 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-125576373-05] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-125576373-06] 49 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-125576373-07] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-125576373-08] |
| Manufacturer | G.L. Pharma GmbH, Lannach, Austrija |
| Marketing Authorisation Holder | G.L. Pharma GmbH, Schlossplatz 1, Lannach, Austrija |
| Marketing Authorisation Date | 16.06.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/105 |
| Registration Number | 381-12-01/171-23-05 |
| Prescription | na recept |
| Type of prescription | poseban recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N07BC51 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
