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ENRYLAZE recombinant crisantaspase 10 mg/0.5 mL solution for injection/infusion vial , Jazz Pharmaceuticals ANZ Pty Ltd, CON-1402
Product name
ENRYLAZE recombinant crisantaspase 10 mg/0.5 mL solution for injection/infusion vial
Sponsor name
Jazz Pharmaceuticals ANZ Pty Ltd
Batches
AU6430B
Consent start
Consent no.
CON-1402
Duration
The consent is effective from 26 August 2025 until 31 March 2026.
Standard
paragraph 8(1)(l) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product is supplied with a modified package insert that does not explicitly
include: - instructions on preparation of the medicine before use, and - details
about how the medicine should be stored, and the maximum time it can be stored
after preparation. Instead of providing this information directly, the insert
includes a QR code and website links to the approved Product Information and
Consumer Medicine Information.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines