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PRODUCT DETAIL

Rotarix perorálna suspenzia vo viacdávkovom obale s jednodávkovými stlačiteľnými tubami

Code 8734C
MA number EU/1/05/330/012
Product Form: sus por 50x1,5 ml (obal viacdávk. s jednod.stlač.tubami-5 jednotl.dávok)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: GlaxoSmithKline Biologicals S.A., Belgium
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J07 VACCINES
J07B VIRAL VACCINES
J07BH Rota virus diarrhea vaccines
J07BH01 Rota virus, live attenuated
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application
MA issued: 21.02.2006
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 25.01.2023
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