Download MARCH 2017 PBAC MEETING – ITEMS AWAITING TGA

MARCH 2017 PBAC MEETING – ITEMS AWAITING TGA OUTCOMES
DRUG NAME, FORM(S),
STRENGTH(S), SPONSOR,
TYPE OF SUBMISSION
MIGALASTAT
DRUG TYPE AND
USE
LISTING REQUESTED BY
SPONSOR / PURPOSE OF
SUBMISSION
PBAC OUTCOME
Fabry disease
To request a Section 100 (Highly
Specialised Drug Program) Authority
Required listing for the treatment of
Fabry disease.
The PBAC recommendation cannot be made public
until the TGA outcome is known.
Hormone receptor
positive, human
epidermal growth
factor receptor 2
(HER2)-negative
advanced breast
cancer
To request an Authority Required
listing with a non-steroidal aromatase
inhibitor (letrozole or anastrozole) as
initial endocrine-based therapy in
postmenopausal women with hormone
receptor positive, HER2 negative
advanced breast cancer.
The PBAC recommendation cannot be made public
until the TGA outcome is known.
Capsule 150 mg
Galafold®
Amicus Therapeutics
New listing
(Major Submission)
PALBOCICLIB
Capsule 75 mg
Capsule 100 mg
Capsule 125 mg
Ibrance®
Pfizer Australia Pty Ltd
New listing
(Major submission)