| ID | 2314 |
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| No | 2314 |
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| Brand Name | HEBERBIOVAC HB |
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| Ingredients | RECOMBINANT DNA HEPATITIS B SURFACE ANTIGEN (HBSAG) 20 MCG/ML |
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| Dosage Form | SUSPENSION FOR INJECTION |
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| Primary Packaging | VIAL |
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| Storage | |
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| Shelf Life | 3 YEARS |
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| Pack Size | 1, 10, 25 VIALS X 1ML/BOX |
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| 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 |
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| Contraindications | |
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| Side Effects | |
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| Unit Price | |
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| EDL | NULL |
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| 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 |
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| Note | |
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| 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 | |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | |
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| FDD Registration No | 08 I 1451/97 |
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| FDD Registration Date | 26/08/2024 |
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| Expiry Date | 25/08/2027 |
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