VELTASSA patiromer (as sorbitex calcium)16.8 g powder for oral suspension sachet, Vifor Pharma Pty Ltd, CON-1112
Product name
VELTASSA patiromer (as sorbitex calcium)16.8 g powder for oral suspension sachet
Sponsor name
Vifor Pharma Pty Ltd
Batches
221268
Consent start
Consent no.
CON-1112
Standard
Paragraph 7 (2)(b)
Subparagraph 10(13)(a)(v)
Subparagraph 10(13)(a)(vi)
Subparagraph 10(13)(a)(x)
Subsection 11 (5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Subparagraph 10(13)(a)(v)
Subparagraph 10(13)(a)(vi)
Subparagraph 10(13)(a)(x)
Subsection 11 (5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply because the sachet labels: - Contain information in
multiple languages; - The product name of the medicines and the name of the
active ingredients are not presented as they appear in the ARTG entry; - The
Sponsor name is recorded as Vifor Fresenius Medical Care Renal Pharma France;
and - The storage conditions say 'Store in refrigerator. Can be stored below
25°C for up to 6 months'.
Conditions imposed
1. A Dear End User letter identical to that provided to the Therapeutic Goods
Administration on 5 June 2023 will be supplied in the product carton describing
the changes.
Therapeutic product type
Prescription medicines