travoprost 0.004% (TRAVATAN) 40 microgram/mL eye drop solution bottle, Alcon Laboratories Australia Pty Ltd, CON-116
Product name
travoprost 0.004% (TRAVATAN) 40 microgram/mL eye drop solution bottle
Sponsor name
Alcon Laboratories Australia Pty Ltd
Consent start
Consent no.
CON-116
Standard
The official standard, the USP monograph for Travoprost Ophthalmic Solution.
Non-compliance with standard
The drug product expiry pH limit is 6.4-7.0 rather than 5.5-6.4 as required by
the official standard.
Conditions imposed
The drug product expiry specifications to which this consent applies are
those currently approved for TRAVATAN (173354).
Therapeutic product type
Prescription medicines