Teruma 14 mg filmom obložene tablete
| Name | Teruma 14 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-404723862 |
| Active Substance | teriflunomid |
| Composition | jedna filmom obložena tableta sadrži 14 mg teriflunomida |
| Pharmaceutical Form | Filmom obložena tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-404723862-01] 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-404723862-02] 14 tableta u blisteru, u kutiji [HR-H-404723862-03] 28 tableta u blisteru, u kutiji [HR-H-404723862-04] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-404723862-05] 30 tableta u blisteru, u kutiji [HR-H-404723862-06] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-404723862-07] 84 tablete u blisteru, u kutiji [HR-H-404723862-08] 84 tablete u blisteru s jediničnom dozom, u kutiji [HR-H-404723862-09] |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
Teva Operations Poland Sp. z o.o., Krakow, Poljska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 26.07.2023 |
| MA Period of Validity | 26.07.2028 |
| Classification Number | UP/I-530-09/21-01/242 |
| Registration Number | 381-12-01/154-23-08 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AA31 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 4 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 4 |
