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PRODUCT DETAIL

Gentamicin Noridem 80 mg/ml

Code 0943F
MA number 15/0291/25-S
Product Form: sol ijf 20x2 ml/160 mg (amp.skl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Noridem Enterprises Ltd., Cyprus
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
J01GB03 Gentamicin
Shelf life: 36
Container: glass ampoule
Route of admin.: Intramuscular or intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 28.08.2025
Validity: 28.08.2030
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Gentamicin Noridem 20 mg_ml, 40 mg_ml, 80 mg_ml_sol ijf_08/2025_REG.pdf  
SPC: SPC_Gentamicin Noridem 20 mg_ml, 40 mg_ml, 80 mg_ml_sol ijf_08/2025_REG.pdf  
Safety feature Yes
Data update: 02.09.2025
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