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REDDY-NILOTINIB DIN 02556626

Status: Approved
Holder: DR REDDY'S LABORATORIES LTD
Molecule: NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)

Health Canada record

Active ingredient(s)NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MG
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01EA03 NILOTINIB
Original market date
Current status date01-Apr-2025
SourceHealth Canada DPD

Establishment licence of the holder

Dr Reddy's Laboratories (UK) Limited — licence , not currently licensed, last inspection rating C (2019-02-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)

DINProductCompanyFormStrengthStatus
02550881APO-NILOTINIBAPOTEX INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02550903APO-NILOTINIBAPOTEX INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MGMarketed
02556642REDDY-NILOTINIBDR REDDY'S LABORATORIES LTDCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MGMarketed
02556634REDDY-NILOTINIBDR REDDY'S LABORATORIES LTDCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02315874TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MGMarketed
02368250TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MGMarketed
02481715TASIGNANOVARTIS PHARMACEUTICALS CANADA INCCapsuleNILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
351042025-04-01Abbreviated New Drug Submission (ANDS)
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