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HAVRIX JUNIOR inactivated hepatitis A vaccine 720 ELISA units/0.5mL injection pre-filled syringe with attached needle without attached needle, GlaxoSmithKline Australia Pty Ltd, CON-440
Product name
HAVRIX JUNIOR inactivated hepatitis A vaccine 720 ELISA units/0.5mL injection pre-filled syringe with attached needle without attached needle
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-440
Standard
Paragraph 10(3)(a) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipients names on the label, aluminium hydroxide, sodium phosphate '“
dibasic and sodium phosphate '“ monobasic, do not align with the Australian
Approved Name (AAN) as required by Section 6 Interpretation, name of an
excipient.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the
information detailed in the submission (PM-2020-02345-1-2);2. The non-compliant
labels will be revised to become fully compliant with TGO 91 on or before 11 May
2021; and3. This exemption applies only to product released in the Australian
market before 11 May 2021.
Therapeutic product type
Blood, tissues, and biologicals