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 |