Actine 20 mg tablete
| Name | Actine 20 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-877459016 |
| Active Substance | bilastin |
| Composition | jedna tableta sadrži 20 mg bilastina |
| Pharmaceutical Form | Tableta |
| Manufacturer | PharmaS d.o.o., Zagreb, Hrvatska Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
| Marketing Authorisation Date | 23.01.2026 |
| MA Period of Validity | 23.01.2031 |
| Classification Number | UP/I-530-09/24-01/150 |
| Registration Number | 381-12-01/171-26-19 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R06AX29 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |