ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection vial, Seqirus Pty Ltd, CON-902
Product name
ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection vial
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-902
Duration
The consent is effective from 24 January 2022 and only applicable to stock imported into Australia prior to 1 August 2022.
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 products do not conform to the requirements of Section 6 and paragraph
8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and
related medicines (TGO 91), in that the contact details (current address) of the
Distributor are not provided on the label of the medicine.
Conditions imposed
1. The consent should apply only to stock imported into Australia with a
manufacture date before 1 August 2022.
2. The carton labels to which this consent applies are those approved 13
December 2019.
Therapeutic product type
Prescription medicines