Medicinal Products

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 L04AK02
Medicinal product marketed in the Croatia Nestašica
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
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