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IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule, Seqirus Pty Ltd, CON-1181
Product name
IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule
Sponsor name
Seqirus Pty Ltd
Batches
All batches of the product released for supply before 30 September 2026
Consent start
Consent no.
CON-1181
Duration
The consent is effective from 16 November 2023 until 30 September 2026.
Standard
paragraph 10(12)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform where the batch number and expiry date prefixes
are not included on the ampoule label.
Conditions imposed
1.The ampoule labels must include the batch number and expiry date.
2. The associated pouch labels must include the batch number and expiry date
immediately after their respective prefixes.
3. The associated carton and pouch labels must include instructions that unused
ampoules must be stored in the associated pouch.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines