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FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for injection, Sanofi Aventis Australia Pty Ltd, CON-408
Product name
FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60mcg, 0.5mL suspension for injection
Sponsor name
Sanofi Aventis Australia Pty Ltd
Batches
Batch - UJ396AB Expiry - 03 March 2021 Quantity - 139,345 doses Packaged as: 5 × syringe pack
Consent start
Consent no.
CON-408
Standard
Subsections 9(3) and 11(5), paragraphs 8(1)(d), 8(1)(i), 9(1)(b),9(1)(c),10(5)(c), 11(1)(a) and subparagraph 8(1)(j)(iv)(A) in the Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines:
Non-compliance with standard
The batch is packaged in the Standard Export labelling (in Spanish and English),
which does not conform with the requirements of the TGO91 on the followinga.
Paragraph8(1)(d) the name of the dosage form (missing on carton).b.
Paragraph8(1)(i) the name and contact details of the sponsor (missing on
carton).c. Subparagraph 8(1)(j)(iv)(A) indicating that the medicine contains the
substance expressed using the Name stated in Column 4 of Schedule 1 (statement
regarding manufactured in eggs missing on carton).d. Paragraph9(1)(b) the
name(s) of all active ingredients in the medicine (missing on
syringe).e.Paragraph9(1)(c) the quantity or proportion of all active ingredients
in the medicine (missing on syringe).f. Subsection9(3) the name of the medicine
and the name of active ingredients on the main label (they are placed separately
as the same texts in Spanish are placed before English texts).g.
Paragraph10(5)(c) the name of the medicine is displayed in a text size of not
less than 1.5 millimetres (the trade name 'FluQuadri' is less than 1.5 mm on
syringe).h. Paragraph 11(1)(a) use of appropriate metric units (the abbreviation
'mcg' is used rather than 'microgram' in full on carton).i. Subsection11(5)
permitted statements of storage temperature conditions ('Store between +2°C to
+8°C. Do not freeze' is used rather than 'Store at 2°C to 8°C' (Refrigerate. Do
not freeze) on carton).
Conditions imposed
1. This consent applies only to the FluQuadri batch UJ396AB.2.A 'Dear Healthcare
Professional' letter identical to that provided to the Therapeutic
GoodsAdministrationinthesubmission of the15 April 2020 will be supplied with the
affected batch.3. Non-compliance with the European Pharmacopoeia is limited to
only Therapeutic Goods Order 91 requirements.
Therapeutic product type
Prescription medicines