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FLUMAZENIL INJECTION, USP DIN 02266342

Status: Marketed
Holder: FRESENIUS KABI CANADA LTD
Molecule: FLUMAZENIL
Available to quote

Health Canada record

Active ingredient(s)FLUMAZENIL 0.1 MG
Dosage formSolution
RouteIntravenous
ScheduleETHICAL
ClassHuman
ATCV03AB25 FLUMAZENIL
Original market date05-Nov-2007
Current status date20-Sep-2025
SourceHealth Canada DPD

Establishment licence of the holder

Fresenius Kabi Canada Ltd. — licence 102232, currently licensed, last inspection rating C (2025-10-01).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing FLUMAZENIL

DINProductCompanyFormStrengthStatus
02249561FLUMAZENIL INJECTIONSANDOZ CANADA INCORPORATEDSolutionFLUMAZENIL 0.1 MGMarketed
02431750JAMP-FLUMAZENILJAMP PHARMA CORPORATIONSolutionFLUMAZENIL 0.1 MGApproved
00874019ANEXATE INJ 0.1MG/MLHOFFMANN-LA ROCHE LIMITEDSolutionFLUMAZENIL 0.1 MGCancelled Post Market
02388995FLUMAZENIL INJECTION SDZSANDOZ CANADA INCORPORATEDSolutionFLUMAZENIL 0.1 MGCancelled Pre Market
02430169FLUMAZENIL INJECTION, USPMYLAN PHARMACEUTICALS ULCSolutionFLUMAZENIL 0.1 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
353262025-05-08Supplement to an Abbreviated New Drug Submission (SANDS)Change in product name. Update to package labels
168872015-05-08Abbreviated New Drug Submission (ANDS)MANUFACTURER AND PRODUCT NAME CHANGE
93642008-02-12Abbreviated New Drug Submission (ANDS)MANUFACTURER NAME CHANGE
83442006-10-24Abbreviated New Drug Submission (ANDS)MANUFACTURER NAME CHANGE
68082005-05-18Supplement to an Abbreviated New Drug Submission (SANDS)PRODUCT NAME CHANGE
63812005-03-30Abbreviated New Drug Submission (ANDS)

International API supply for FLUMAZENIL

4 valid EDQM Certificates of Suitability from 4 holders. 4 active FDA Drug Master Files.

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