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NDSAC meeting of September 9, 2018

A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on September 9, 2018 to consider the following matters:

  • Request for Schedule III status for esomeprazole magnesium trihydrate 20 mg delayed release capsules when sold for the 14-day treatment for frequent heartburn for the following package sizes: 280 mg (14 capsules), 560 mg (28 capsules), 840 mg (42 capsules).

The committee did not want to finalize its recommendations until it has the opportunity to review the final revisions to the product monograph and labelling regarding drug interactions that the applicant has submitted to Health Canada.

The 30-day consultation period will not begin until the committee has reviewed the final revisions to the Health Canada approved product monograph and labelling regarding drug interactions. Once this occurs, the committee will finalize its draft recommendations and forward them to the NAPRA Board of Directors, which will trigger the start of the 30-day consultation period.

A subsequent notice will be posted on the NAPRA website and circulated to the Drug Scheduling External Liaison Group once the committee has finalized its draft recommendations.

Date:

Source: NAPRA