View drug registration information details.
| Items | Registration information |
|---|
| ID | 365 |
|---|
| No | 365 |
|---|
| Brand Name | ITAZOL |
|---|
| Ingredients | ITRACONAZOLE PELLETS EQ.TO ITRACONAZOLE USP 100 MG |
|---|
| Dosage Form | CAPSULE |
|---|
| Primary Packaging | ALU-PVC STRIP |
|---|
| Storage | STORE IN A COOL DRY PLACE, PROTECTED FROM LIGHT AND MOISTURE |
|---|
| Shelf Life | 2 YEARS |
|---|
| Pack Size | BOX OF 1 X 8'S |
|---|
| Dispensing Category | PRESCRIPTION ONLY |
|---|
| ATC Classification | J02AC02 |
|---|
| Pharmaceutical Class | ANTIFUNGAL |
|---|
| Indications | 1.BLASTOMYCOSIS, PULMONARY AND EXTRAPULMONARY.2. HISTOPLASMOSIS INCLUDING CHRONIC CAVITARY PULMONARY DISEASE AND DISSEMINATED, NON-MENINGEAL HISTOPLASMOSIS. 3. ASPERGILLOSIS, PULMONARY AND EXTRAPULMONARY, IN PATIENTS WHO ARE INTOLERANT OF ORWHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY |
|---|
| Contraindications | KNOWN HYPERSENSITIVITY |
|---|
| Side Effects | LIVER FAILURE, HEADACHE, ABDOMINAL PAIN, NAUSEA, |
|---|
| Unit Price | |
|---|
| EDL |
No |
|---|
| Description | WHITE TO OFF WHITE PELLETS FILLED IN SIZE"0" CAPSULES HAVING PEARLZ BLUE CAP AND PEARZ BLUE BODY PRINTED UNITOED BIOTECH ON CAP PACKED IN BLISTER OF 8 CAPSULES AND PACK IN A PRINTED MONO CARTON ALONG WITH INSET |
|---|
| Note | |
|---|
| License Owner | CBF PHARMA CO.,LTD |
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| Manufacturer | UNITED BIOTECH (P) LIMITED |
|---|
| Country | INDIA |
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| Import Registration No | MNB/05/254 |
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| Import Registration Date | 2021-03-03 |
|---|
| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2021-09-24 |
|---|
| FDD Registration No | 10 I 5314/22 |
|---|
| FDD Registration Date | 2022-11-11 |
|---|
| Expiry Date | 2025-11-10 |
|---|
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