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ItemsRegistration information
ID1076
No1076
Brand NameIC - GATE EYE DROPS
IngredientsGATIFLOXACIN SESQUIHYDRATE USP EQ. TO GATIFLOXACIN 0.3% W/V
Dosage FormEYE DROPS
Primary PackagingBOTTE
StorageSTORE BELOW 30'C PROTECTED FROM LIGHT, DO NOT FREEZ.
Shelf Life24 MONTH THE DATE OF MANUFACTURING
Pack Size5 ML/BOTTLE/BOX
Dispensing CategoryPrescription only
ATC ClassificationXX
Pharmaceutical ClassTOPICAL ANTIBACTERIA
IndicationsTREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF THE FOLLOWING AEROBIC GRAM - POSITIVE AND GRAM - NEGATIVE BACTERIA SUCH AS S.AUREUS, S. EPIDERMIDIS, S. PNEUMONIAE, S. MITIS, COMYEBACTERIUM PROPINQUULM AND HAEMOPHILLUS INFLUENZA.
ContraindicationsIC - GATE EYE DROP IS CONTRAINDICATION IN PATIENTS WITH A HISTORY OF HYPERSENSITIVITY TO GATIFLOXACIN TO OTHER QUINOLONES, OR TO ANY OF THE COMPONENTS IN THIS MEDICATION.
Side EffectsTHE MOST FREQUENTLY REPORTED ADVERSE EVENTS IN THE OVERALL STUDY POPULATION WERE CONJUCTIVITIS. OTHER REPORTED REACTIONS WERE CHEMOSIS.
Unit Price-
EDL No
DescriptionCLEAR, COLORLESS SOLUTION FILLED IN PLASTIC VIALS
Note
License OwnerIC Pharma Lao Co., Ltd
ManufacturerHEALTH BIOTECH LTD
CountryINDIA
Import Registration NoMB/05/158
Import Registration Date20.8/2020
ActivityCERTIFICATE RELEASED
Applied Date2022-10-28
FDD Registration No10 I 4288/17
FDD Registration Date2023-04-28
Expiry Date2026-04-27

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