Midazolam-Baxter midazolam (as hydrochloride) 15 mg/3 mL solution for injection ampoule, Baxter Healthcare Pty Ltd, CON-393
Product name
Midazolam-Baxter midazolam (as hydrochloride) 15 mg/3 mL solution for injection ampoule
Sponsor name
Baxter Healthcare Pty Ltd
ARTG
Batches
#B5B0476
Consent start
Consent no.
CON-393
Standard
Paragraphs 4(k), 4(j), 5(g)Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
1.The route of administration is not included on the label.2.The name of the
sponsor as it appears on the primary pack or registered trademark that readily
identifies the sponsor is not included on the label.
Conditions imposed
The number must be overstickered on all affected cartons of each batch.
Therapeutic product type
Prescription medicines