ERAXIS anidulafungin 100 mg powder for injection vial, Pfizer Australia Pty Ltd , CON-1261
Product name
ERAXIS anidulafungin 100 mg powder for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Batches
HF4183
Consent start
Consent no.
CON-1261
Standard
Subsection 9(5)
Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(o), 9(1)(g), 9(3)(a)(i), 10(3)(a)(ii), 10(3)(b), 11(2)(f)(v)
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(o), 9(1)(g), 9(3)(a)(i), 10(3)(a)(ii), 10(3)(b), 11(2)(f)(v)
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The carton label does not include the quantity of active ingredient in a text
size of not less than 3.0 millimetres; does not include the approved name of
dosage form; batch number and expiry date are not immediately preceded by the
batch number and expiry date prefixes; does not include the name of the medicine
on three non-opposing sides; does not include the name of the medicine and the
name and quantity of the active ingredient as a cohesive unit; does not include
the name and quantity of each excipient in the medicine; does not include the
words 'for infusion' adjacent to the name of the dosage form; does not include
the statement 'Use in one patient on one occasion only. Contains no
antimicrobial preservative' or words to that effect; and the quantity of the
active ingredient is not expressed as the stated weight of the active ingredient
in the stated volume of fill of the injection in the container. The vial label
does not include the approved name of dosage form; batch number and expiry date
are not immediately preceded by the batch number and expiry date prefixes; does
not include the name and quantity of each excipient in the medicine; does not
include the statement 'Use in one patient on one occasion only. Contains no
antimicrobial preservative' or words to that effect.
Conditions imposed
1. A Dear Healthcare Professional letter identical to that provided with the
application dated 31 July 2024 will be supplied with the affected batch.
2. The will be over-stickered on the carton as advised in your email
correspondence to the TGA dated 8th August 2024
3. The carton label to which this consent applies is that provided in your
email correspondence to the TGA dated 8th August 2024
4. The vial label to which this consent applies is that provided with the
letter of application dated 31 July 2024.
Therapeutic product type
Prescription medicines