GANFORT PF 0.3/5 bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL eye drops, Abbvie Pty Ltd, CON-1231
Product name
GANFORT PF 0.3/5 bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL eye drops
Sponsor name
Abbvie Pty Ltd
Consent start
Consent no.
CON-1231
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not have the current sponsor name and address on the label. The
details on the label are for the previous sponsor Allergan Australia Pty. Ltd.
whilst the current sponsor is AbbVie Pty Ltd.
Conditions imposed
The current risk mitigations strategies included in the application regarding
contacting the sponsor will remain in place for the length of the exemption.
This includes the website redirection as well as retaining the current customer
service number that is included on the label.
Therapeutic product type
Prescription medicines