November 2010 PBAC Outcomes - Deferrals

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November 2010 PBAC Outcomes - Deferrals

Drug and Form

Drug Use and Type

Listing Requested by Sponsor

PBAC Outcome and Comment

Adrenaline, injections, 150 mcg in 0.3 mL and 300 mcg 0.3 mL, single dose syringe auto-injector, EpiPen Jr® and EpiPen®

Alphapharm Pty Ltd

Minor submission
Severe allergic reactions A change from an Authority Required listing to an Authority Required (Streamlined) listing was requested. The PBAC deferred making a recommendation to seek comment on the proposed change from the Australasian Society of Clinical Immunology and Allergy (ASCIA).
Sponsor’s comments: Alphapharm supports the decision to seek comment from the ASCIA.
Sponsor’s comments: Alphapharm welcomes the inclusion of a note to indicate that the capsule and tablet formulations may be substituted.