DEFINITY perflutren lipid microsphere injection vial, Global Medical Solutions Australia Pty Limited t/a Radpharm Scientific, CON-487
Product name
DEFINITY perflutren lipid microsphere injection vial
Sponsor name
Global Medical Solutions Australia Pty Limited t/a Radpharm Scientific
Consent start
Consent no.
CON-487
Standard
Paragraphs 8(3)(b), 9(1)(b) and 10(4)(e) and Section 8(1)(i) and 10(4)(j) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The products do not state the active ingredient names as per the Australian
Approved Name and do not include the name and address of the current sponsor.
Therapeutic product type
Prescription medicines