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Istodax (romidepsin) 10mg powder for injection vial, and solvent for reconstitution vial , Bristol-Myers Squibb Australia Pty Ltd, CON-1399
Product name
Istodax (romidepsin) 10mg powder for injection vial, and solvent for reconstitution vial
Sponsor name
Bristol-Myers Squibb Australia Pty Ltd
Consent start
Consent no.
CON-1399
Duration
The consent is effective from 13 August 2025 until 1 May 2026.
Standard
Paragraph 8(1)(i) and subparagraph 10(3)(a)(ii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because: - The labels include the contact details of
the previous sponsor (Celegene Pty Ltd) in place of the current sponsor
(Bristol-Myers Squibb Australia Pty Ltd ), following a transfer of the
sponsorship of the products. - The labels do not include the excipient,
hydrochloric acid (quantity 'q.s').
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines