Medicinal Products

Apiksaban Teva GmbH 5 mg filmom obložene tablete

Name Apiksaban Teva GmbH 5 mg filmom obložene tablete
Former Name Apiksaban Teva 5 mg filmom obložene tablete
Marketing Authorisation Number HR-H-741399572
Active Substance apiksaban
Composition jedna filmom obložena tableta sadrži 5 mg apiksabana
Pharmaceutical Form filmom obložena tableta
Manufacturer Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
Marketing Authorisation Holder TEVA GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka
Marketing Authorisation Date 14.01.2026
MA Period of Validity unlimited
Classification Number UP/I-530-09/25-02/02
Registration Number 381-12-01/70-26-19
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product on medical prescription for renewable delivery
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code B01AF02
Marketing status Never marketed
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Public Assessment Report download
Summary of risk management plan download

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