IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule, Seqirus Pty Ltd, CON-924
Product name
IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule
Sponsor name
Seqirus Pty Ltd
Batches
4Q36K-R
Consent start
Consent no.
CON-924
Standard
Paragraphs 10(12)(d) and 10(12)(e) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The product ampoule does not state the batch number of the medicine preceded by
the batch number prefix and the expiry date of the medicine preceded by the
expiry date prefix.
Conditions imposed
1. The carton and intermediate foil labels are the currently approved labels
and instruct patients to keep the ampoules in the pouch. The carton and
intermediate foil labels are over stickered with the revised batch and
expiry details as outlined in the letter of application.
2. Explanatory letters will be provided advising wholesalers, prescribers and
pharmacists about why this batch has been overstickered and, to alert them
to the discrepancy between the expiry date on the ampoule and that on the
foil pouch and outer carton.
Therapeutic product type
Prescription medicines