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RECOMBIVAX HB DIN 02561484

Status: Marketed
Holder: MERCK CANADA INC
Molecule: HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

Health Canada record

Active ingredient(s)HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG
Dosage formSolution
RouteIntramuscular
ScheduleSCHEDULE D
ClassHuman
ATCJ07BC01 HEPATITIS B, PURIFIED ANTIGEN
Original market date14-Apr-2026
Current status date14-Apr-2026
SourceHealth Canada DPD

Establishment licence of the holder

Merck Canada Inc — licence 101380, currently licensed, last inspection rating C (2023-07-17).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

DINProductCompanyFormStrengthStatus
02487020ENGERIX-BGLAXOSMITHKLINE INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCGMarketed
02487039ENGERIX-BGLAXOSMITHKLINE INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 20 MCGMarketed
02533286PREHEVBRIOVBI VACCINES INC.SuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCGApproved
02561476RECOMBIVAX HBMERCK CANADA INCSolutionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 5 MCGMarketed
02245977RECOMBIVAX HBMERCK CANADA INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 40 MCGMarketed
02237548TWINRIX JUNIORGLAXOSMITHKLINE INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG; HEPATITIS A VIRUS, INACTIVATED 360 UNITMarketed
02296454ENGERIX-BGLAXOSMITHKLINE INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCGCancelled Post Market
01919431ENGERIX-BGLAXOSMITHKLINE INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 20 MCGCancelled Post Market
02243676RECOMBIVAX HBMERCK CANADA INCSuspensionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCGCancelled Post Market
01934023RECOMBIVAX HB (ADULT DIALYSIS WITH PRESERVATIVE)MERCK CANADA INCSolutionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 40 MCGCancelled Post Market
00749486RECOMBIVAX HB (WITH PRESERVATIVE)MERCK CANADA INCSolutionHEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
361922025-09-26Supplement to a New Drug Submission (SNDS)Product Monograph update and new presentation
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