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BRILINTA DIN 02455005

Status: Marketed
Holder: ASTRAZENECA CANADA INC
Molecule: TICAGRELOR
Available to quote

Health Canada record

Active ingredient(s)TICAGRELOR 60 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCB01AC24 TICAGRELOR
Original market date13-Jun-2016
Current status date13-Jun-2016
SourceHealth Canada DPD

Establishment licence of the holder

AstraZeneca Canada Inc. — licence 100421, currently licensed, last inspection rating C (2023-06-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TICAGRELOR

DINProductCompanyFormStrengthStatus
02537192AG-TICAGRELORANGITA PHARMA INC.TabletTICAGRELOR 90 MGMarketed
02537184AG-TICAGRELORANGITA PHARMA INC.TabletTICAGRELOR 60 MGMarketed
02482630APO-TICAGRELORAPOTEX INCTabletTICAGRELOR 90 MGMarketed
02482622APO-TICAGRELORAPOTEX INCTabletTICAGRELOR 60 MGMarketed
02368544BRILINTAASTRAZENECA CANADA INCTabletTICAGRELOR 90 MGMarketed
02531798JAMP TICAGRELORJAMP PHARMA CORPORATIONTabletTICAGRELOR 60 MGMarketed
02531801JAMP TICAGRELORJAMP PHARMA CORPORATIONTabletTICAGRELOR 90 MGMarketed
02529750M-TICAGRELORMANTRA PHARMA INCTabletTICAGRELOR 60 MGMarketed
02529769M-TICAGRELORMANTRA PHARMA INCTabletTICAGRELOR 90 MGMarketed
02492571TARO-TICAGRELORTARO PHARMACEUTICALS INCTabletTICAGRELOR 60 MGMarketed
02492598TARO-TICAGRELORTARO PHARMACEUTICALS INCTabletTICAGRELOR 90 MGMarketed
02471922TEVA-TICAGRELORTEVA CANADA LIMITEDTabletTICAGRELOR 90 MGApproved
02471914TEVA-TICAGRELORTEVA CANADA LIMITEDTabletTICAGRELOR 60 MGApproved

Notices of Compliance

NOCDateSubmissionReason
181512016-05-30Supplement to a New Drug Submission (SNDS)TO ADD A NEW STRENGTH OF 60 MG TABLET AND NEW INDICATION: PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION (MI OCCURED AT LEAST ONE YEAR AGO) AND A HIGH RISK OF DEVELOPING AN ATHEROTHROMBOTIC EVENT

International API supply for TICAGRELOR

23 valid EDQM Certificates of Suitability from 23 holders. 47 active FDA Drug Master Files.

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