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PRODUCT DETAIL

Sandimmun 50 mg/ml

Code 95041
MA number 59/0123/83-CS
Product Form: con inf 10x1 ml/50 mg (amp.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AD Calcineurin inhibitors
L04AD01 Ciclosporin
Shelf life: 48
Container: glass ampoule
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 22.11.1984
Pediatric warnings: Yes
SPC: SPC_Sandimmun 50 mg_ml infúzny koncentrát_08.2023.pdf  
PIL: PIL_Sandimmun 50 mg_ml infúzny koncentrát_08.2023.pdf  
Safety feature Yes
Data update: 05.06.2018
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