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IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule, Seqirus Pty Ltd, CON-953
Product name
IKERVIS ciclosporin 1 mg/mL eye drops emulsion ampoule
Sponsor name
Seqirus Pty Ltd
Batches
7Q58 (7Q58V) and 2R08 (2R08G)
Consent start
Consent no.
CON-953
Duration
The consent is effective from the 8 June 2022 until 30 November 2022.
Standard
Paragraphs 10(12)(c) and 10(12)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not include the quantity of the medicine, nor the approved
route of administration on the ampoule label.
Conditions imposed
A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutic Goods Adimistration on 7 June 2022 will be supplied with each
affected batch.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines