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ROVAMYCINE 250 CAPSULE 750000 UNIT DIN 01927825

Status: Cancelled Post Market
Holder: ODAN LABORATORIESLTD
Molecule: SPIRAMYCIN
Available to quote

Health Canada record

Active ingredient(s)SPIRAMYCIN 750000 UNIT
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCJ01FA02 SPIRAMYCIN
Original market date31-Dec-1957
Current status date20-Jun-2023
SourceHealth Canada DPD

Establishment licence of the holder

Odan Laboratories Ltd. — licence 100025, currently licensed, last inspection rating C (2024-03-12).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SPIRAMYCIN

DINProductCompanyFormStrengthStatus
01927817ROVAMYCINE 500 CAPSULE 1500000 UNITODAN LABORATORIESLTDCapsuleSPIRAMYCIN 1500000 UNITCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
59122004-11-14New Drug Submission (NDS)MANUFACTURER NAME CHANGE
14692000-11-01New Drug Submission (NDS)

International API supply for SPIRAMYCIN

3 valid EDQM Certificates of Suitability from 3 holders. 0 active FDA Drug Master Files.

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