IKERVIS ciclosporin 1 mg/mL eye drops, emulsion ampoule, Seqirus Pty Ltd, CON-686
Product name
IKERVIS ciclosporin 1 mg/mL eye drops, emulsion ampoule
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-686
Standard
Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of paragraphs 8(3)(d), 8(3)(e)
and 10(12)(d) of Therapeutic Goods Order No 91 - Standard for labels of
prescription and related medicines (TGO 91), in that the batch number prefix is
not printed immediately before the batch number on the carton label, the expiry
date prefix is not printed immediately before the expiry date on the carton
label, and the batch number and expiry date prefixes are not included on the
ampoule label.
Conditions imposed
The carton label must include the batch number and expiry date prefixes
close to the batch number and expiry date.
The ampoule labels must include the batch number and expiry date.
The associated pouch labels must include the batch number and expiry date
immediately after their respective prefixes.
The associated carton and pouch labels must include instructions that
unused ampoules must be stored in the associated pouch.
Therapeutic product type
Prescription medicines