View drug registration information details.
| Items | Registration information |
|---|
| ID | 323 |
|---|
| No | 323 |
|---|
| Brand Name | KETOCONAZOLE TABLET 200 MG |
|---|
| Ingredients | KETOCONAZOLE 200 MG |
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| Dosage Form | TABLET |
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| Primary Packaging | BLISTERPACK |
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| Storage | STORE BELOW 30 C, PROTECT FROM LIGHT |
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| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 10 X 10'S |
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| Dispensing Category | Prescription only |
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| ATC Classification | J02AB02 |
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| Pharmaceutical Class | ANTIFUNGAL |
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| Indications | TREATMENT OF THE FOLLOWING SYSTEMIC FUNGAL INFECTIONS IN PATIENTS WHO HAVE FAILED OR WHO ARE INTOLERANT TO OTHER THERAPIES:BLASTOMYCOSIS, COCCIDIOIDOMYCOSIS, HISTOPLASMOSIS, CHROMOMYCOSIS AND PARACOCCIDIOIDOMYCOSIS |
|---|
| Contraindications | IN PATIENTS WITH ACUTE OR CHRONIC LIVER DISEASE OR WITH A KNOWN HYPERSENSITIVITY, WHEN CO-ADMINISTERED WITH TERFENADINE, ASTEMIZOLE AND CISAPRIDE. |
|---|
| Side Effects | HEPATITIS, HYPERSENSITIVITY, SKIN RASH, PRURITUS, DIARRHEA, NAUSEA, VOMITTING, CONSTIPATION, ABDOMINAL PAIN, DIZZINESS, DROWNSINESS, HEADACHE, GYNAECOMASTIA, IMPOTENCE, MENSTRUAL IRREGULARITIES, PHOTOPHOBIA, SOMNOLENCE, THROMBOCYTOPENIA, |
|---|
| Unit Price | 6.1 |
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| EDL |
Yes |
|---|
| Description | ROUND, 10 MM IN DIAMETER, WHITE UNCOATED TABLET, BEVEL-EDGED, SHALLOW CONVEX FACES, HD AND BREAK-BAR EMBOSSED ON ONE FACE |
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| Note | |
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| License Owner | BMS PHARMA SOLE CO.,LTD |
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| Manufacturer | HOVID BHD |
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| Country | MALAYSIA |
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| Import Registration No | MAL19987375AZ |
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| Import Registration Date | 28/09/2013 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2022-03-29 |
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| FDD Registration No | 05 I 4705/19 |
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| FDD Registration Date | 2022-09-08 |
|---|
| Expiry Date | 2025-09-07 |
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