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KORSUVA difelikefalin (as acetate) 50 microgram/1 mL solution for injection vial, Seqirus Pty Ltd, CON-1269
Product name
KORSUVA difelikefalin (as acetate) 50 microgram/1 mL solution for injection vial
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-1269
Duration
The consent is effective from 29 August 2024 until 1 September 2025.
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not contain the correct name or address of the sponsor.
Conditions imposed
Arrangements are in place with the former sponsor Vifor Pharma for the prompt referral of any queries or complaints concerning the products to Seqirus Pty Ltd [the current sponsor].
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines