Teriflunomid Teva 14 mg filmom obložene tablete
| Name | Teriflunomid Teva 14 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-868867157 |
| Active Substance | teriflunomid |
| Composition | jedna filmom obložena tableta sadrži 14 mg teriflunomida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska Teva Operations Poland Sp. z o.o., Krakow, Poljska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 23.08.2023 |
| MA Period of Validity | 23.08.2028 |
| Classification Number | UP/I-530-09/21-01/243 |
| Registration Number | 381-12-01/286-23-08 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AK02 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
