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PRODUCT DETAIL

Octagam 5 %

Code 0590D
MA number 59/0050/19-S
Product Form: sol inf 2x200 ml/10 g (fľ.skl.infúzna)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J06 IMMUNE SERA AND IMMUNOGLOBULINS
J06B IMMUNOGLOBULINS
J06BA Immunoglobulins, normal human
J06BA02 Immunoglobulins, normal human, for intravascular application
Shelf life: 24
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 25.02.2019
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Octagam 5%_08.2023.pdf  
PIL: PIL_Octagam 5%_08.2023.pdf  
Safety feature Yes
Data update: 07.06.2023
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