CEQUA ciclosporin 900 microgram/mL eye drops ampoule, Sun Pharma ANZ Pty Ltd, CON-354
Product name
CEQUA ciclosporin 900 microgram/mL eye drops ampoule
Sponsor name
Sun Pharma ANZ Pty Ltd
Consent start
Consent no.
CON-354
Standard
Paragraph 10(12)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO No. 91)
Non-compliance with standard
The batch number prefix is not included on ampoule label.
Conditions imposed
The ampoule labels must include the batch number.
The associated carton and pouch labels must include the batch number
prefix and batch number.
The associated carton and pouch labels must include instructions that
unused ampoules must be stored in the associated pouch.
Therapeutic product type
Prescription medicines