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ItemsRegistration information
ID577
No577
Brand NameOMEPREX 40
IngredientsOMEPRAZOLE USP 40 MG
Dosage FormPOWDER FOR SOLUTION FOR INJECTION
Primary PackagingVIAL
StorageSTORE IN A COOL, DRY AND DARK PLACE, BELOW 30 C, PROTECT FROM MOISTURE AND LIGHT
Shelf Life3 YEARS
Pack SizeBOX OF 1 VIAL/BOX
Dispensing CategoryPRESCRIPTION
ATC ClassificationA02BC01
Pharmaceutical ClassANTIULCER
IndicationsTREATMENT OF DUODENAL ULCERS, PREVENTION OF RELAPSE OF DUODENAL ULCER, TREATMENT OF GASTRIC ULCER, PREVENTION OF RELAPSE OF GASTRIC ULCER, TREATMENT OF NSAID ASSOCIATED GASTRIC AND DUODENAL ULCERS
ContraindicationsHYPERSENSITIVITY TO OMEPRAZOLE OR TO ANY OF THE EXIPIENT
Side EffectsHEADACHE, ABDOMINAL PAIN, CONSTIPATION, DIARRHEA, FLATULENCE, NAUSEA, VOMITING
Unit Price
EDL Yes
DescriptionWHITE TO ALMOST WHITE LYOPHILIZED, ODORLESS, HYGROSCOPIC POWDER FILLED IN 10 ML CLEAR COLOR GLASS VIAL
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerCOTEC HEALTHCARE PVT LTD
CountryINDIA
Import Registration No40/UA/SC/P-2010
Import Registration Date2016-09-02
ActivityCERTIFICATE RELEASED
Applied Date2021-02-05
FDD Registration No12 I 5346/22
FDD Registration Date2022-12-30
Expiry Date2025-12-29

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