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Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (100 mg/5 mL) injection BP ampoule, Bridgewest Perth Pharma Pty Ltd, CON-1135
Product name
Pfizer (Australia) LIGNOCAINE HYDROCHLORIDE 2% (100 mg/5 mL) injection BP ampoule
Sponsor name
Bridgewest Perth Pharma Pty Ltd
Consent start
Consent no.
CON-1135
Duration
The consent is effective from 24 July 2023 until 31 July 2025.
Standard
Paragraph 10(4) (c), Paragraph 10(4) (d), 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.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines