Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule, Seqirus Pty Ltd, CON-1038
Product name
IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-1038
Standard
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
Non-compliance with standard
The product 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
1. The carton label must include the batch number and expiry date prefixes in
immediate proximity to the batch number and expiry date (as outlined in the
application).
2. The ampoule labels must include the batch number and expiry date.
3. The associated pouch labels must include the batch number and expiry date
immediately after their respective prefixes.
4. The associated carton and pouch labels must include instructions that unused
ampoules must be stored in the associated pouch.
Therapeutic product type
Prescription medicines