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TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) injection multidose vial, Global Medical Solutions Australia Pty Limited, CON-489

Product name
TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) injection multidose vial
Sponsor name
Global Medical Solutions Australia Pty Limited
Consent start
Consent no.
CON-489
Standard
Paragraphs 8(1)(b) and 8(1)(i) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The name of the ingredients on the medicine carton and container labels are not consistent with the Australian Approved Names, in particularMolybdenum Mo 99 should be molybdenum(99Mo)Technetium Tc 99m should be technetium(99mTc)Sodium pertechnetate Tc 99m should be Sodium pertechnetate(99mTc).Additionally, the labels do not include the name and address of the current sponsor Global Medical Solutions Australia Pty Limited, and instead refer to the previous sponsor Lantheus Medical Imaging.
Therapeutic product type
Prescription medicines

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