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PRODUCT DETAIL

APEL 600 mg filmom obalené tablety

Code 0647D
MA number 15/0059/19-S
Product Form: tbl flm 20x600 mg (blis.PVC/PVDC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
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
J01XX08 Linezolid
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 08.03.2019
PIL: PIL_APEL 600 mg filmom obalené tablety_marec_2019.docx  
SPC: SPC_APEL 600 mg filmom obalené tablety_02.2022.pdf  
Safety feature Yes
Data update: 19.03.2023
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