Telirem 14 mg filmom obložene tablete
| Name | Telirem 14 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-557547366 |
| Active Substance | teriflunomid |
| Composition | jedna filmom obložena tableta sadrži 14 mg teriflunomida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Coripharma ehf., Hafnarfjoerdur, Island Remedica Ltd., Limassol, Cipar |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 22.05.2024 |
| MA Period of Validity | 22.05.2029 |
| Classification Number | UP/I-530-09/23-01/85 |
| Registration Number | 381-12-01/70-24-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L04AK02 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
