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KOSELUGO GRANULES DIN 02569744

Status: Approved
Holder: ALEXION PHARMA GMBH
Molecule: SELUMETINIB (SELUMETINIB SULFATE)

Health Canada record

Active ingredient(s)SELUMETINIB (SELUMETINIB SULFATE) 7.5 MG
Dosage formGranules
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01EE04 SELUMETINIB
Original market date
Current status date02-Jul-2026
SourceHealth Canada DPD

Establishment licence of the holder

Alexion Pharma Canada Corp — licence 101731, currently licensed, last inspection rating C (2026-02-04).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SELUMETINIB (SELUMETINIB SULFATE)

DINProductCompanyFormStrengthStatus
02530139KOSELUGOALEXION PHARMA GMBHCapsuleSELUMETINIB (SELUMETINIB SULFATE) 10 MGMarketed
02530147KOSELUGOALEXION PHARMA GMBHCapsuleSELUMETINIB (SELUMETINIB SULFATE) 25 MGMarketed
02569736KOSELUGO GRANULESALEXION PHARMA GMBHGranulesSELUMETINIB (SELUMETINIB SULFATE) 5 MGApproved

Notices of Compliance

NOCDateSubmissionReason
378342026-07-02Supplement to a New Drug Submission (SNDS)Addition of new indication: KOSELUGO Granules: the treatment of pediatric patients aged 1 year and older, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas / Addition of new dosage form: granules / Addition of new strength: 5 mg and 7.5 mg
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