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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
Duration
The consent is effective from 1 September 2023 until 1 June 2024.
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.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines