March 2008 PBAC Outcomes - Deferrals
|
Drug and Form |
Drug Use and Type |
Listing Requested by Sponsor |
PBAC Outcome and Comment |
|---|---|---|---|
| ALENDRONATE SODIUM with COLECALCIFEROL, tablet, equivalent to 70 mg alendronic acid
with 140 micrograms colecalciferol, Fosamax Plus® 70/140 Merck Sharp and Dohme (Australia) Pty Ltd Minor submission |
Osteoporosis | Authority required (streamlined) listing similar to Fosamax Plus® (alendronic acid 70 mg with colecalciferol 70 micrograms). | The PBAC deferred a final decision pending registration of the product by the Therapeutic Goods Administration. |
| Sponsor’s comments | The sponsor had no comment. | ||
| MELOXICAM, tablets, 7.5 mg and 15 mg and capsules, 7.5 mg and 15 mg, Mobic® Boehringer Ingelheim Pty Ltd Minor submission |
Anti-inflammatory agent | Restricted benefit listing for symptomatic relief of rheumatoid arthritis. | The PBAC deferred a recommendation on this item, noting that it had never formally assessed meloxicam for this use. |
| Sponsor’s comments | The sponsor had no comment |
