KYPROLIS carfilzomib 60 mg powder for injection vial, Amgen Australia Pty Ltd, CON-1009
Product name
KYPROLIS carfilzomib 60 mg powder for injection vial
Sponsor name
Amgen Australia Pty Ltd
Consent start
Consent no.
CON-1009
Standard
Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 '“ Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that,
on the cartons the contact details of the distributor of the medicine are not
current.
Therapeutic product type
Prescription medicines