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ItemsRegistration information
ID1045
No1045
Brand NameDEFERASIROX GPO
IngredientsDEFERASIROX 250 MG
Dosage FormDISPERSIBLE TABLET
Primary PackagingNYLON/ALU/PVC BLISTER
StorageDO NOT STORE ABOVE 30C, STORE IN THE ORIGNAL CONTAINER
Shelf Life2 YEARS
Pack SizeBOX OF 3 X 10'S
Dispensing CategoryPrescription only
ATC ClassificationV03AC03
Pharmaceutical ClassIRON CHELATING AGENT
IndicationsTREATMENT OF CHRONIC IRON OVERLOAD DUE TO BLOOD TRANSFUSIONS IN ADULT AND PEDIATRIC PATIENTS (AGED 2 YEARS AND OVER). ALSO INDICATED FOR THE TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS WITH NONTRANSFUSION-DEPENDENT THALASSEMIA SYNDROMS AGED 10 YEARS AND OLDER
ContraindicationsCRCL LESS THAN 40 ML/MIN OR SERUM CREATININE GREATER THAN 2 TIMES THE AGE-APPROPRIATE ULN. POOR PERFORMANCE STATUS, HIGH RISK MYELODYSPLASTIC SYNDROMES, ADVANCED MALIGNANCIES, PLATELET COUNTS LESS THAN 50 X 10^19/L, KNOWN HYPERSENSITIVITY
Side EffectsABDOMINALPAIN, DIARRHEA, NAUSEA,VOMITING, INCREASE IN SERUM CREATININE, RASH
Unit Price
EDL No
DescriptionOFF WHITE, FLATE, ROUND, COMPRESSED TABLETS, ONE SIDE DEBOSEED WITH "D250" AND THE OTHER SIDE DEBOSSED WITH "GPO"
Note
License OwnerKARNYA VIENGNAKORN EXPORT-IMPORT
ManufacturerTHE GOVERNMENT PHARMACEUTICAL ORGANISATION
CountryTHAILAND
Import Registration No1A 7/61 (NG)
Import Registration Date2018-02-05
ActivityCERTIFICATE RELEASED
Applied Date2024-08-26
FDD Registration No12 I 5163/21
FDD Registration Date2024-09-10
Expiry Date2029-09-09

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