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Pfizer (Australia) MIDAZOLAM INJECTION midazolam 5mg/5mL injection ampoule, Pfizer Australia Pty Ltd, CON-1385
Product name
Pfizer (Australia) MIDAZOLAM INJECTION midazolam 5mg/5mL injection ampoule
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1385
Duration
The consent is effective from 10 July 2025 until 30 September 2026.
Standard
Paragraph 10(4)(d); 10(4)(f) and 10(4)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because the ampoule label is missing the active
ingredient name separate from the name of the medicine, the name of the dosage
form ‘injection, solution’ and the volume is only included as part of the
quantity of the active ingredient.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines