View drug registration information details.
| Items | Registration information |
|---|
| ID | 2314 |
|---|
| No | 2314 |
|---|
| Brand Name | HEBERBIOVAC HB |
|---|
| Ingredients | RECOMBINANT DNA HEPATITIS B SURFACE ANTIGEN (HBSAG) 20 MCG/ML |
|---|
| Dosage Form | SUSPENSION FOR INJECTION |
|---|
| Primary Packaging | VIAL |
|---|
| Storage | |
|---|
| Shelf Life | 3 YEARS |
|---|
| Pack Size | 1, 10, 25 VIALS X 1ML/BOX |
|---|
| Dispensing Category | |
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| ATC Classification | |
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| Pharmaceutical Class | |
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| Indications | FOR THE ACTIVE IMMUNIZATION AGAINST INFECTION BY HBV INFECTION AND PREVENTION OF ITS POTENTIAL OUTCOMES SUCH AS ACUTE AND CHRONIC HEPATITIS, CIRRHOSIS OF THE LIVER AND PRIMARY CARCINOMA |
|---|
| Contraindications | |
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| Side Effects | |
|---|
| Unit Price | |
|---|
| EDL |
NULL |
|---|
| Description | WHITE GRAYISH SUSPENSION, SLIGHTLY OPAQUE, WHICH SEPARATES, AFTER SOME SEDIMENTATION TIME, INTO TWO PHASES: ONE LIQUID AND TRANSPARENT, AND ANOTHER ONE UNDER THE FORM OF GEL, WHICH, WHEN SHAKEN, EASILY RE-SUSPENDS AND WHICH IS FREE OF ODD PARTICLES |
|---|
| Note | |
|---|
| License Owner | SOKDY OSOTH IMPORT-EXPORT CO., LTD |
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| Manufacturer | CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY |
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| Country | CUBA |
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| Import Registration No | |
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| Import Registration Date | |
|---|
| Activity | CERTIFICATE RELEASED |
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| Applied Date | |
|---|
| FDD Registration No | 08 I 1451/97 |
|---|
| FDD Registration Date | 26-AUG-2024 |
|---|
| Expiry Date | 25-AUG-2027 |
|---|
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