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ENERZAIR BREEZHALER DIN 02501244

Status: Marketed
Holder: NOVARTIS PHARMACEUTICALS CANADA INC
Molecule: MOMETASONE FUROATE
Available to quote

Health Canada record

Active ingredient(s)MOMETASONE FUROATE 160 MCG; INDACATEROL (INDACATEROL ACETATE) 150 MCG; GLYCOPYRRONIUM (GLYCOPYRROLATE) 50 MCG
Dosage formCapsule
RouteInhalation
SchedulePRESCRIPTION
ClassHuman
ATCR03AL12 INDACATEROL, GLYCOPYRRONIUM BROMIDE AND MOMETASONE
Original market date05-Nov-2020
Current status date05-Nov-2020
SourceHealth Canada DPD

Establishment licence of the holder

Novartis Pharmaceuticals Canada Inc — licence 100273, currently licensed, last inspection rating C (2025-01-14).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing MOMETASONE FUROATE

DINProductCompanyFormStrengthStatus
02403587APO-MOMETASONEAPOTEX INCSpray (Metered-Dose)MOMETASONE FUROATE 50 MCGMarketed
02438690ASMANEX TWISTHALERORGANON CANADA INC.PowderMOMETASONE FUROATE 100 MCGMarketed
02243595ASMANEX TWISTHALERORGANON CANADA INC.PowderMOMETASONE FUROATE 200 MCGMarketed
02243596ASMANEX TWISTHALERORGANON CANADA INC.PowderMOMETASONE FUROATE 400 MCGMarketed
00871095ELOCOMORGANON CANADA INC.LotionMOMETASONE FUROATE 0.1 %Marketed
00851744ELOCOMORGANON CANADA INC.CreamMOMETASONE FUROATE 0.1 %Marketed
00851736ELOCOMORGANON CANADA INC.OintmentMOMETASONE FUROATE 0.1 %Marketed
02451905NASAL ALLERGY AND CONGESTION RELIEFAPOTEX INCSpray (Metered-Dose)MOMETASONE FUROATE 50 MCGApproved
02238465NASONEXORGANON CANADA INC.Spray (Metered-Dose)MOMETASONE FUROATE 50 MCGMarketed
02244768PMS-MOMETASONEPHARMASCIENCE INCLotionMOMETASONE FUROATE 0.1 %Approved
02244767PMS-MOMETASONEPHARMASCIENCE INCCreamMOMETASONE FUROATE 0.1 %Approved
02566613PRO-MOMETASONEPRO DOC LIMITEESpray (Metered-Dose)MOMETASONE FUROATE 50 MCGApproved
02367157TARO-MOMETASONE CREAMTARO PHARMACEUTICALS INCCreamMOMETASONE FUROATE 0.1 %Marketed
02266385TARO-MOMETASONE LOTIONTARO PHARMACEUTICALS INCLotionMOMETASONE FUROATE 0.1 %Marketed
02475863TEVA-MOMETASONETEVA CANADA LIMITEDSpray (Metered-Dose)MOMETASONE FUROATE 50 MCGMarketed
02248130TEVA-MOMETASONETEVA CANADA LIMITEDOintmentMOMETASONE FUROATE 0.1 %Marketed
02361760ZENHALEORGANON CANADA INC.Aerosol (Metered-Dose)MOMETASONE FUROATE 200 MCG; FORMOTEROL FUMARATE DIHYDRATE 5 MCGMarketed
02361752ZENHALEORGANON CANADA INC.Aerosol (Metered-Dose)MOMETASONE FUROATE 100 MCG; FORMOTEROL FUMARATE DIHYDRATE 5 MCGMarketed
02410524NASONEX ALLERGY AND CONGESTIONMERCK CANADA INCSpray (Metered-Dose)MOMETASONE FUROATE 50 MCGCancelled Pre Market
02244769PMS-MOMETASONEPHARMASCIENCE INCOintmentMOMETASONE FUROATE 0.1 %Cancelled Post Market
02270862PMS-MOMETASONEPHARMASCIENCE INCOintmentMOMETASONE FUROATE 0.1 %Cancelled Post Market
02264749TARO-MOMETASONE OINTMENTTARO PHARMACEUTICALS INCOintmentMOMETASONE FUROATE 0.1 %Dormant
02361744ZENHALEORGANON CANADA INC.Aerosol (Metered-Dose)MOMETASONE FUROATE 50 MCG; FORMOTEROL FUMARATE DIHYDRATE 5 MCGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
238542020-07-02New Drug Submission (NDS)

International API supply for MOMETASONE FUROATE

14 valid EDQM Certificates of Suitability from 13 holders. 35 active FDA Drug Master Files.

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