KORSUVA difelikefalin (as acetate) 50 microgram/1 mL solution for injection vial, Seqirus Pty Ltd, CON-1247
Product name
KORSUVA difelikefalin (as acetate) 50 microgram/1 mL solution for injection vial
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-1247
Standard
Paragraph 8(1)(l), Paragraph 8(1)(o), Paragraph 9(1)(b), Subparagraph 9(1)(f)(i), Paragraph 9(3)(a), Subparagraph 10(3)(a)(i), Paragraph 11(2)(a), Subparagraph 11(2)(f)(v), Paragraph 11(5)(vi), Paragraph 10(5)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because it will be supplied with an international
label that contains the following non-compliance: - The pack insert required for
8(1)(l) is an internationally approved insert and not the approved Australian
PI. - The name(s) of the active ingredient is "difelikefalin (as acetate)". It
is expressed on the main panel as both "difelikefalin (as acetate)" and
"difelikefalin". - The approved route of administration (intravenous) not
present. - The name of the medicine and the name of the active ingredient does
not appear as a cohesive unit. - The quantity or proportion of the active
ingredient not expressed as quantity in the discrete dosage unit. - The medicine
for injection is for single use and the stated weight of the active ingredient
in the stated volume of the injection container is not present. - The storage
temperature is expressed as "Do not freeze. Store below 30 °C" rather than that
specified in approved product details i.e. "Store below 30 °C. Do not freeze. -
The name and quantity of each excipient in the single dose injection is not
present the container is less than 3mL in capacity and the primary pack label
doesn't comply with sections 8 and 9 and subsection 10(3).
Conditions imposed
1. Dear Healthcare Provider' letter identical to that provided to the TGA on 5
July 2024 will be supplied with each affected carton describing the differences
between the registered label and the international label.
2. The sponsor will use over stickering to include the number, the Signal
headings and to establish a main label. There will be a second sticker including
the sponsor contact details on a side panel. This will be identical to that
provided in the communication dated 24 may and 5 June 2024.
Therapeutic product type
Prescription medicines