View drug registration information details.
Items | Registration information |
ID | 89 |
No | 89 |
Brand Name | TS-ONE CAPSULE 25 |
Ingredients | TEGAFUR 25 MG, GIMERACIL 7.25 MG, OTERACIL POTASSIUM 24.5 MG |
Dosage Form | CAPSULE |
Primary Packaging | BLISTERPACK |
Storage | STORE BELOW 30 C |
Shelf Life | 4 YEARS |
Pack Size | BOX OF 4 X 14'S |
Dispensing Category | Prescription only |
ATC Classification | X |
Pharmaceutical Class | ANTINEOPLASTIC |
Indications | GASTRIC CANCER, COLORECTAL CANCER, HEAD AND NECK CANCER, NON-SMALL CELL LUNG CANCER, INOPERABLE OR RECURRENT BREAST CANCER, PANCREATIC CANCER, BILIARY TRACT CANCER |
Contraindications | HYPERSENSITIVITY, SEVERE BONE MARROW DEPRESSION, SEVERE RENAL DISORDER, HEPATIC DISORDER, RECIEVING TREATMENT WITH FLUCYTOSINE, PREGNANT |
Side Effects | BONE MARROW DEPRESSION, FULMINANT HEPATITIS, DEHYDRATION, SEVERE ENTERTITIS, ANOSMIA, ACUTE PANCREATITIS, INTESTITIAL PNEUMONIA |
Unit Price | |
EDL |
No |
Description | AN OPAQUE HARD CAPSULE WITH ORANGE CAP AND WHITE BODY, CONTAINING WHITE POWDER AND GRANULES |
Note | |
License Owner | AI KEN PHARMA CO., LTD |
Manufacturer | TAIHO PHARMACEUTICAL CO.,LTD TOKUSHIMA PLANT |
Country | JAPAN |
Import Registration No | 22100AMX00887000 |
Import Registration Date | 2009-06-12 |
Activity | F3 MAR |
Applied Date | 2025-02-28 |
FDD Registration No | 10 I 4620/18 |
FDD Registration Date | 2022-05-13 |
Expiry Date | 2025-05-12 |
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