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ZEMAIRA DIN 02494779

Status: Approved
Holder: CSL BEHRING CANADA INC
Molecule: ALPHA1-PROTEINASE INHIBITOR (HUMAN)

Health Canada record

Active ingredient(s)ALPHA1-PROTEINASE INHIBITOR (HUMAN) 5000 MG
Dosage formKit; Powder For Solution
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02AB02 ALFA1 ANTITRYPSIN
Original market date
Current status date16-Dec-2019
SourceHealth Canada DPD

Establishment licence of the holder

CSL Behring Canada Inc. — licence 101328, currently licensed, last inspection rating C (2026-01-13).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ALPHA1-PROTEINASE INHIBITOR (HUMAN)

DINProductCompanyFormStrengthStatus
02522438GLASSIATAKEDA CANADA INCSolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MGMarketed
02571250GLASSIATAKEDA CANADA INCSolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 5000 MGApproved
02571242GLASSIATAKEDA CANADA INCSolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000 MGApproved
02204606PROLASTIN-CGRIFOLS THERAPEUTICS LLCPowder For SolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MGMarketed
02488787PROLASTIN-C LIQUIDGRIFOLS THERAPEUTICS LLCSolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MGApproved
02543028PRONEXTICA LIQUIDGRIFOLS THERAPEUTICS LLCSolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MGApproved
02494760ZEMAIRACSL BEHRING CANADA INCKit; Powder For SolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000 MGApproved
02457911ZEMAIRACSL BEHRING CANADA INCPowder For Solution; KitALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MGApproved
02223651ALPHA1-PROTEINASE INHIBITOR (HUMAN)GRIFOLS THERAPEUTICS LLCPowder For SolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 1 GCancelled Pre Market
02223643ALPHA1-PROTEINASE INHIBITOR (HUMAN)GRIFOLS THERAPEUTICS LLCPowder For SolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 500 MGCancelled Pre Market
00803529PROLASTIN INJ 25.0MG/MLCUTTER BIOLOGICAL, DIVISION OF MILES LAB INC.Powder For SolutionALPHA1-PROTEINASE INHIBITOR (HUMAN) 25 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
230332019-12-16Supplement to a New Drug Submission (SNDS)Introduction of two additional drug product presentations
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