PATENT BLUE V 50 mg/2 mL injection ampoule, Guerbet Australia Pty Ltd, CON-1201
Product name
PATENT BLUE V 50 mg/2 mL injection ampoule
Sponsor name
Guerbet Australia Pty Ltd
Consent start
Consent no.
CON-1201
Standard
Paragraph 7(2)(b), Subparagraph 8(1)(m)(i), Subparagraph 9(1)(f)(i), Paragraph 10(5)(c), Paragraph (10)(5)(g), Paragraph 10(5)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product uses an international label that includes text in French and
English, including the product name and active ingredient in French spelling.
The label includes intra-arterial as a route of administration which is not
approved in Australia.
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 6 December 2023 will be supplied with each
affected batch warning that the intro-arterial route of administration is not
approved in Australia.
Therapeutic product type
Prescription medicines