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PRODUCT DETAIL

Penlac 500 mg/125 mg

Code 5014D
MA number 15/0117/20-S
Product Form: tbl flm 5x500 mg/125 mg (blis.OPA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J01C BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01CR Combinations of penicillins, incl. beta-lactamase
J01CR02 Amoxicillin and enzyme inhibitor
Shelf life: 24
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 08.07.2020
Validity: 08.07.2025
Pediatric indication: Yes
Pediatric posology: Yes
PIL: PIL_Penlac 500mg_125mg_tbl flm_05.2023.pdf  
SPC: SPC_Penlac 500mg_125mg_tbl flm_05.2023.pdf  
Safety feature Yes
Data update: 09.07.2020
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