How much time does MAH have to update the existing PAAB approved APS that are still effective after a new version of Product Monograph has received NOC.
Please see Q&A 377, 485 and Update of APS per new boxed warning in PM.
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How much time does MAH have to update the existing PAAB approved APS that are still effective after a new version of Product Monograph has received NOC.
Please see Q&A 377, 485 and Update of APS per new boxed warning in PM.