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PRODUCT DETAIL

Xenleta 150 mg koncentrát a rozpúšťadlo na infúzny roztok

Code 5331D
MA number EU/1/20/1457/001
Product Form: cif fol 2x150 mg + solv. 2x250 ml (liek.inj.skl. + vak inf.PP)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J01X OTHER ANTIBACTERIALS
J01XX Other antibacterials
J01XX12 Lefamulin
Shelf life: 36
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 27.07.2020
Validity: 27.07.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.08.2020
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