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MIDAZOLAM VIATRIS 5 mg/5 mL midazolam solution for injection ampoule, Alphapharm Pty Ltd, CON-1294
Product name
MIDAZOLAM VIATRIS 5 mg/5 mL midazolam solution for injection ampoule
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-1294
Duration
The consent is effective from 11 November 2024 until 7 November 2025.
Standard
Paragraph 8(1)(i), paragraph 9(1)(b), paragraph 9(1)(b), paragraph 9(3)(a), paragraph 10(4)(f), and paragraph 10(4)(k) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product is supplied with a New Zealand label. This label includes the New
Zealand contact details for the sponsor. It does not include the name of the
active ingredient or the dosage form on the main label. The name of the medicine
and the active ingredient are not expressed as a cohesive unit. The label used
on the vial does not contain the dosage form or the route of administration for
the medicine.
Conditions imposed
A Dear Pharmacist letter will be supplied with each affected batch describing
the differences between the approved and supplied labels.
A sticker includes the Poison Standard Signal headings and Registration (AUST R)
number will be added to the main label of the medicine.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines