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ItemsRegistration information
ID366
No366
Brand NameOMEPAZ
IngredientsOMEPRAZOLE SODIUM EQ. TO OMEPRAZOLE 40 MG
Dosage FormPOWDER FOR SOLUTION FOR INJECTION
Primary PackagingVIAL
StorageSTORE IN A COOL, DRY PLACE, TEMPERATURE BELOWE 25'C, PROTECTED FROM LIGHT.
Shelf Life3 YEARS
Pack SizeBOX OF 1 VIAL AND 1 AMPOULE WITH 10 ML WATER FOR INJECTION
Dispensing CategoryPrescription only
ATC ClassificationA02BC01
Pharmaceutical Classantiulcer
IndicationsTREATMENT OF DUODENAL ULCERS, PREVENTION OF RELAPSE OF DUODENAL ULCERS, TREATMENT AND PREVENTION OF RELAPSE OF GASTRIC ULCERS, TREATMENT AND PREVENTION OF NSAID-ASSOCIATED GASTRIC AND DUODENAL ULCERS IN PATIENTS AT RISK, TREATMENT OF REFLUX OESOPHAGITIS, TREATMENT OF ZOLLINGER-ELLISON SYNDROME.
ContraindicationsHYPERSENSITIVITY TO OMEPRAZOLE SUBSTITUTED BENZIMIDAZOLES OR TO ANY OF THE EXCIPIENTS
Side EffectsTHE MOST COMMON SIDE EFFECTS (1-10% OF PATIENTS) ARE HEADACHE, ABDOMINAL PAIN,CONSTIPATION, DIARRHEA, FLATULENCE AND NAUSEA/VOMITING.
Unit Price-
EDL Yes
DescriptionWHITE OR ALMOST WHITE LOOSE POWDER
Note
License OwnerCBF PHARMA CO.,LTD
ManufacturerCISEN PHARMACEUTICAL CO.,LTD
CountryCHINA
Import Registration NoGYZZ H20083922
Import Registration Date2018-04-04
ActivityCERTIFICATE RELEASED
Applied Date2022-03-21
FDD Registration No11 I 3926/13
FDD Registration Date2023-08-14
Expiry Date2026-08-13

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