| ID | 104 |
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| No | 104 |
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| Brand Name | REVAC - B+ |
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| Ingredients | EACH ADULT DOSE OF 1.0 ML CONTAINS: HEPATITIS B SURFACE ANTIGEN >=20 MCG |
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| Dosage Form | SUSPENSION FOR INJECTION |
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| Primary Packaging | VIAL |
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| Storage | STORE BELOW +2'C TO 8'C |
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| Shelf Life | 3 YEARS |
|---|
| Pack Size | BOX OF 1 VIAL X 1 ML |
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| Dispensing Category | Prescription only |
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| ATC Classification | J06BB04 |
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| Pharmaceutical Class | VACCINES, ANTISERA & IMMUNOLOGICALS |
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| Indications | FOR IMMUNIZATION OF PERSONS AGAINST INFECTION BY HEPATITIS - B VIRUS AND ITS COMMON SUB -TYPES. IT CAN ALSO BE GIVE TO HEPATITIS C AND D VIRUS INFECTED PATIENTS TO PROTECT THEM AGAINST CO-INFECTION WITH HEPATITIS -B |
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| Contraindications | ROVAC -B+ IS GENERALLY WELL TOLERATED. HOWEVER THE VACCINE SHOULD NOT BE ADMINISTERED OR REPEATED TO PERSONS KNOWN TO BE HYPERSENSITIVE TO ANY OF THE COMPONENTS OF THE VACCINE. |
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| Side Effects | REVAC B+ HAS PROVEN LOW REACTOGENICITY AND IS WELL TOLERATED. OPEN AND COMPARATIVE TRIALS DID NOT SHOW ADVERSE REACTIONS IN THE VACCINEES. |
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| Unit Price | - |
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| EDL |
Yes |
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| Description | WHITE OR ALMOST WHITE, TRANSLUCENT LIQUID, FREE FROM PARTICULATE MATTER BY VISUAL OBSERVATION |
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| Note | |
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| License Owner | ARAVANH PHARMA SOLE CO.,LTD |
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| Manufacturer | BHARAT BIOTECH INTERNATIONAL LIMITED |
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| Country | INDIA |
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| Import Registration No | 03/HD/AP/98/V/R/ IN FORM 28 -D |
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| Import Registration Date | 1998-10-14 |
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| Activity | CERTIFICATE RELEASED |
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| Applied Date | 2021-08-27 |
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| FDD Registration No | 07 I 3861/13 |
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| FDD Registration Date | 2022-05-30 |
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| Expiry Date | 2025-05-29 |
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