EVUSHELD tixagevimab 100 mg/ mL and cilgavimab 100 mg/ mL solution for injection in 150 mg single dose vials, AstraZeneca Pty Ltd, CON-952
Product name
EVUSHELD tixagevimab 100 mg/ mL and cilgavimab 100 mg/ mL solution for injection in 150 mg single dose vials
Sponsor name
AstraZeneca Pty Ltd
ARTG
378245
Consent start
Consent no.
CON-952
Standard
Section 6, Section 8(1)(d), Section 8(1)(i), Section 8(2), Section 9(1)(d), Section 9(3)(a) and (b), Section 9(5), Section 10(4)(f) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product label does not comply with the TGO 91 regarding the following
information A blanket exemption for TGO91 compliance is approved for the
international artworks presented. The main non-compliances with TGO91 are ' the
excipients 'L-histidine' and 'L-histidine hydrochloride monohydrate' are not
named as per the Australian Approved Names. ' the dosage form 'solution for
injection' is shown as ' injection' and 'each 1.5 mL of solution contains'¦' '
the sponsor address is not included as they are international artworks. Details
can be found by scanning the QR code or going to 'laab.azcovid-19.com'. ' the
international cartons do not include a dispensing label. ' 'injection' is
included on the main panel and 'solution' is included on the back panel as part
of 'each 1.5mL of solution contains'¦' ' the name of the medicine, active
ingredient and quantity are not presented in the required cohesive layout. ' the
name of the active ingredients and quantity have a text height of less than 3.0
millimetres. ' the dosage form is described as 'injection' on the vial labels.
Conditions imposed
A Dear Health Care Professional Letter (DHCPL) will be distributed for the
Evusheld stock supplied in exempted international labels. The DHCPL will provide
details on the label changes.
Therapeutic product type
Prescription medicines