Teriflunomid Abdi 14 mg filmom obložene tablete
| Name | Teriflunomid Abdi 14 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-646898499 |
| Active Substance | teriflunomid |
| Composition | jedna filmom obložena tableta sadrži 14 mg teriflunomida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Flavine Pharma France, Vitrolles, Francuska Interpharma Services Ltd., Sofia, Bugarska |
| Marketing Authorisation Holder | Abdi Farma GmbH, Donnersbergstrasse 4, Heppenheim, Njemačka |
| Marketing Authorisation Date | 30.08.2023 |
| MA Period of Validity | 30.08.2028 |
| Classification Number | UP/I-530-09/22-01/107 |
| Registration Number | 381-12-01/171-23-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L04AK02 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 5 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 4 |
