Vamtexar 500 mg/20 mg tablete s prilagođenim oslobađanjem
| Name | Vamtexar 500 mg/20 mg tablete s prilagođenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-804314032 |
| Active Substance | naproksen esomeprazolmagnezij trihidrat |
| Composition | jedna tableta s prilagođenim oslobađanjem sadrži 500 mg naproksena i 20 mg esomeprazola (u obliku esomeprazolmagnezij trihidrata) |
| Pharmaceutical Form | Tableta s prilagođenim oslobađanjem |
| Manufacturer | Interpharma Services Ltd., Sofia, Bugarska Flavine Pharma France, Vitrolles, Francuska Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 25.10.2024 |
| MA Period of Validity | 25.10.2029 |
| Classification Number | UP/I-530-09/22-01/237 |
| Registration Number | 381-12-01/70-24-09 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for non-renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | M01AE52 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
