LUXTURNA voretigene neparvovec 5 x 10(12) (vg) per mL concentrate solution for injection vial with diluent ampoule, Novartis Pharmaceuticals Australia Pty Limited, CON-1156
Product name
LUXTURNA voretigene neparvovec 5 x 10(12) (vg) per mL concentrate solution for injection vial with diluent ampoule
Sponsor name
Novartis Pharmaceuticals Australia Pty Limited
Consent start
Consent no.
CON-1156
Standard
Folding Box:
' Section 9(3)(a)
' Section 10(3)(a)(i)
' Section 10(2)(f):
' Section 8(1)(i):
' Section 8(1)(o):
Pouch:
' Section 9(3)(a):
' Section 8(1)(i) & 8(3)(f):
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
' Section 9(3)(a)
' Section 10(3)(a)(i)
' Section 10(2)(f):
' Section 8(1)(i):
' Section 8(1)(o):
Pouch:
' Section 9(3)(a):
' Section 8(1)(i) & 8(3)(f):
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product label does not comply with TGO 91 in that: Folding Box: ' The Active
ingredient is not immediately under the tradename. ' The AAN and excipient
amount missing (injectable). ' The Statement "Use in one patient on one
occasion. Contains no antimicrobial preservative" is missing. ' The AU sponsor
address is missing. ' There are not 3 sides with the tradename. Pouch: ' The
Active ingredient is not immediately under the tradename. ' The AU sponsor
address is missing.
Therapeutic product type
Prescription medicines