Pfizer (Australia) CHLORHEXIDINE 0.1% irrigation solution ampoule, Bridgewest Perth Pharma Pty Ltd, CON-1133
Product name
Pfizer (Australia) CHLORHEXIDINE 0.1% irrigation solution ampoule
Sponsor name
Bridgewest Perth Pharma Pty Ltd
Consent start
Consent no.
CON-1133
Standard
Paragraph 8(1) (i), Subsection 9(4), Subsection 9(5), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) have print direct stamped onto the plastic ampoules (TECA print)
and do not comply with the requirements of TGO 91. This is due to the ampoule
labels being physically unable to encompass all requirements as prescribed by
TGO 91 due to limited available printable area.
Therapeutic product type
Prescription medicines