ATGAM equine antithymocyte immunoglobulin 250 mg/5 mL injection ampoule, Pfizer Australia Pty Ltd, CON-1124
Product name
ATGAM equine antithymocyte immunoglobulin 250 mg/5 mL injection ampoule
Sponsor name
Pfizer Australia Pty Ltd
Batches
GY8471
Consent start
Consent no.
CON-1124
Standard
Section 8(1)(o)
Section 8(1)(b), Section 9(1)(b) & Section 10(4)(d)
Section 11(2)(f)(v)
Section 10(3)(a)
Section 8(1)(d)
Section 9(1)(g)
Section 10(3)(b)
Section 9(1)(e)
Section 10(4)(f)
Section 10(4)(h) and (i)
Section 10(4)(j) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Section 8(1)(b), Section 9(1)(b) & Section 10(4)(d)
Section 11(2)(f)(v)
Section 10(3)(a)
Section 8(1)(d)
Section 9(1)(g)
Section 10(3)(b)
Section 9(1)(e)
Section 10(4)(f)
Section 10(4)(h) and (i)
Section 10(4)(j) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
- Name of the medicine is not stated on at least 3 non opposing sides of the
carton. - Active ingredient is expressed differently to the AAN in the ARTG
Entry. - Proportion of active ingredient is expressed differently. - The name
and quantity of excipients are not all stated and expressed as nominal mass in
the stated volume of fill of the injection in the container. - Dosage form,
'Injection, solution' is expressed differently, - 'for infusion' is not
displayed adjacent to the name of the dosage form. - Statement regarding use in
one patient on one occasion only and contains no antimicrobial preservative is
missing. - Quantity of the medicine is not stated on the main label of the
carton, however, is stated on other panels of the carton. - Dosage form,
'injection, solution' is not stated on the ampoule label. - Batch and expiry
details is not immediately preceded by the batch number prefix on the ampoule
label. - Incorrect sponsor detail is on the ampoule label; however, 'Pfizer' is
mentioned.
Conditions imposed
1. The Sponsor is required to over sticker the US product carton with the
Australian sponsor details, the number, signal headings and a direction
to not administer the product undiluted.
2. A 'Dear Healthcare Professional' letter will be supplied with the affected
batch warning that the product is a US-labelled product supplied with section 14
consent.
Therapeutic product type
Prescription medicines