MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine, GlaxoSmithKline Australia Pty Ltd, CON-238
Product name
MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine
Sponsor name
GlaxoSmithKline Australia Pty Ltd
ARTG
Consent start
Consent no.
CON-238
Standard
Subclauses 3(1)(b)(ii), 3(2)(e), 3(2)(g), 3(2)(n), 3(3), 3(2)(j), 3(2)(l), and 3(11)(c) of the Therapeutic Goods Order No. 69.
Non-compliance with standard
The product is supplied in Canadian packaging.
Conditions imposed
1. GlaxoSmithKline puts in place communication and educational material as
outlined in the application and in the email correspondence provided to
Therapeutic Goods Administration on 14, 15, 18 and 19 December 2017 .
2. The batches supplied will only be provided to the Western Australian (WA)
Government ACWY immunisation program and that the WA government has agreed to
accept product labelled in Canadian packaging for this purpose.
Therapeutic product type
Prescription medicines