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BENPEN benzylpenicillin (as sodium) 1.2 g powder for injection vial, Seqirus Pty Ltd, CON-947
Product name
BENPEN benzylpenicillin (as sodium) 1.2 g powder for injection vial
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-947
Duration
The consent is effective for all relevant batches supplied from 1 June 2022 until 1 June 2024.
Standard
Paragraph 8(1)(b) of TGO 91 of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform with Paragraph 8(1)(b) of the Therapeutic Goods
Order No. 91 - Standard for labels of prescription and related medicines (TGO
91) in that the name of the active ingredients is incorrect according to the
AAN.
Conditions imposed
Regulatory action is to be taken to correct the name of the active ingredient
on the product(s) labels and in the ARTG entry within the next three months, or
when the next batch is imported, whichever is sooner. Upon correction of the
name of the active ingredient on the product(s) labels and in the ARTG entry,
these corrections are to be communicated to healthcare professionals to avoid
any confusion regarding the amount of active ingredient present in the
product(s).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines