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ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution prefilled syringe , Guerbet Australia Pty Ltd, CON-1405
Product name
ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution prefilled syringe
Sponsor name
Guerbet Australia Pty Ltd
Batches
25PS3053
Consent start
Consent no.
CON-1405
Duration
The consent is effective from 10 September 2025 until 26 November 2026.
Standard
Paragraph 8(1)(e) 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 quantity of the medicine is included on
the carton as 7,5 mL instead of 7.5 mL in one instance.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines