Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
BENPEN benzylpenicillin (as sodium) 3 g powder for injection vial, Seqirus Pty Ltd, CON-948
Product name
BENPEN benzylpenicillin (as sodium) 3 g powder for injection vial
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-948
Standard
Section 1.1(2)(e) of part 2 of the current Poisons Standard
Non-compliance with standard
The requirement in Section 1.1(2)(e) of Part 2 of the current Poisons Standard
does not apply to a word, expression or statement on a container (which has a
capacity of 20 mL or less), or on the label of such a container, of the
specified products as the use of letters smaller than 1.5 mm in height is
approved. Note Under section 1.1(3)(b) of part 2 of the current Poisons
Standard, the letters on a container, or label of a container, of the specified
products must be at least 1 mm in height.
Therapeutic product type
Prescription medicines