VARILRIX HSA-FREE varicella vaccine live attenuated 0.5 mL injection vial plus diluent syringe composite pack, GlaxoSmithKline Australia Pty Ltd, CON-432
Product name
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5 mL injection vial plus diluent syringe composite pack
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-432
Standard
Section 10(3)(a) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipient name on the label does not align with the Australian Approved Name
(AAN). Excipient name on label is lactose, excipient AAN is lactose monohydrate.
Conditions imposed
1. Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to the
information detailed in the submission (PM-2020-02350-1-2);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
Prescription medicines