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RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent pre-filled syringe, Seqirus Pty Ltd, CON-772
Product name
RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent pre-filled syringe
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-772
Standard
Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of section 6 and paragraph
8(1)(i) of TGO 91, in that the name and contact details of the current Sponsor
are not on the label of the medicine.
Conditions imposed
The labels to which this consent applies are those previously approved for
the former Sponsor, GlaxoSmithKline Australia Pty Ltd.
Arrangements are in place until 1 February 2023 with GlaxoSmithKline
Australia Pty Ltd for the prompt referral of any queries or complaints
concerning the products to Seqirus Pty Ltd.
Therapeutic product type
Prescription medicines