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Indacaterol glycopyrronium mometasone furoate

Last Updated: October 5, 2020
Result type: Reports
Project Number: SR0645-000
Product Line: Common Drug Review

Generic Name: indacaterol glycopyrronium mometasone furoate

Brand Name: Enerzair Breezhaler

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Indications: Asthma maintenance, adults

Manufacturer Requested Reimbursement Criteria1: Indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months.

Submission Type: New

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input openMarch 31, 2020
Call for patient input closedMay 21, 2020
Clarification:

- Patient input submission received from Asthma Canada and Lung Health Foundation

Submission receivedMay 19, 2020
Submission acceptedJune 02, 2020
Review initiatedJune 03, 2020
Draft CADTH review report(s) provided to sponsor for commentAugust 18, 2020
Deadline for sponsors commentsAugust 27, 2020
CADTH responses on draft review report(s) provided to sponsorOctober 08, 2020
Expert committee meeting (initial)October 21, 2020
Draft recommendation issuedNovember 02, 2020
To
November 04, 2020