July 2013 PBAC Outcomes - Items Awaiting a TGA outcome
|
Drug and Form |
Drug Use and Type |
Listing Requested by Sponsor |
PBAC Recommendation |
|---|---|---|---|
|
Mometasone with eformoterol, metered dose inhaler, 50 mcg-5 mcg, 100 mcg-5 mcg and 200 mcg-5 mcg, Zenhale®
Merck Sharp & Dohme (Australia) Pty Limited
Major submission |
Asthma |
Restricted benefit listing for patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate and mometasone furoate. |
The PBAC recommendation cannot be made public until the TGA outcome is known. |
|
Strontium ranelate with colecalciferol, sachet containing strontium ranelate 2 g – colecalciferol 25 mcg, 28, Protos D®
Servier Laboratories (Australia) Pty Ltd
Major submission |
Osteoporosis |
Authority required (Streamlined) listing as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density (BMD) T-score of -3.0 or less, and, established osteoporosis where the patient has had a fracture due to minimal trauma. |
The PBAC recommendation cannot be made public until the TGA outcome is known. |
