View drug registration information details.
Items | Registration information |
ID | 1045 |
No | 1045 |
Brand Name | DEFERASIROX GPO |
Ingredients | DEFERASIROX 250 MG |
Dosage Form | DISPERSIBLE TABLET |
Primary Packaging | NYLON/ALU/PVC BLISTER |
Storage | DO NOT STORE ABOVE 30C, STORE IN THE ORIGNAL CONTAINER |
Shelf Life | 2 YEARS |
Pack Size | BOX OF 3 X 10'S |
Dispensing Category | Prescription only |
ATC Classification | V03AC03 |
Pharmaceutical Class | IRON CHELATING AGENT |
Indications | TREATMENT 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 |
Contraindications | CRCL 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 Effects | ABDOMINALPAIN, DIARRHEA, NAUSEA,VOMITING, INCREASE IN SERUM CREATININE, RASH |
Unit Price | |
EDL |
No |
Description | OFF WHITE, FLATE, ROUND, COMPRESSED TABLETS, ONE SIDE DEBOSEED WITH "D250" AND THE OTHER SIDE DEBOSSED WITH "GPO" |
Note | |
License Owner | KARNYA VIENGNAKORN EXPORT-IMPORT |
Manufacturer | THE GOVERNMENT PHARMACEUTICAL ORGANISATION |
Country | THAILAND |
Import Registration No | 1A 7/61 (NG) |
Import Registration Date | 2018-02-05 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2024-08-26 |
FDD Registration No | 12 I 5163/21 |
FDD Registration Date | 2024-09-10 |
Expiry Date | 2029-09-09 |
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