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. |
