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PRODUCT DETAIL

ARIKAYCE liposomal 590 mg disperzia pre rozprašovač

Code 5844D
MA number EU/1/20/1469/001
Product Form: dis neb 28x590 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01GB Other aminoglycosides
J01GB06 Amikacin
Shelf life: 36
Container: glass vial
Route of admin.: Inhalation use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 27.10.2020
Validity: 27.10.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 04.11.2020
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