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ONUREG azacitidine 300 mg film-coated tablet blister pack, Bristol-Myers Squibb Australia Pty Ltd, CON-1416
Product name
ONUREG azacitidine 300 mg film-coated tablet blister pack
Sponsor name
Bristol-Myers Squibb Australia Pty Ltd
Batches
N2031IA
Consent start
Consent no.
CON-1416
Duration
The consent is effective from 29 September 2025 until 1 February 2026.
Standard
Paragraph 8(1)(i) and section 6 of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product do not conform because the labels remain with the previous sponsor’s
name (Celgene Pty Ltd) and contact details beyond twelve months after
Bristol-Myers Squibb Company (BMS) acquisition of Celgene Pty Ltd.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines