Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (400 mg/20 mL) injection BP ampoule, Bridgewest Perth Pharma Pty Ltd, CON-1136
Product name
Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (400 mg/20 mL) injection BP ampoule
Sponsor name
Bridgewest Perth Pharma Pty Ltd
Consent start
Consent no.
CON-1136
Standard
Paragraph 10(4) (f), Paragraph 10(4) (k), SubParagraph 10(15) (b) (vi), 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 as described in the
attachment. 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