amifostine (as trihydrate) (ETHYOL) 500 mg powder for injection vial, Link Medical Products Pty Ltd, CON-60
Product name
amifostine (as trihydrate) (ETHYOL) 500 mg powder for injection vial
Sponsor name
Link Medical Products Pty Ltd
ARTG
63789
Batches
CK 2071
Consent start
Consent no.
CON-60
Standard
sub-clause 3(1)(a) of the Therapeutic Goods Order No. 69.
Non-compliance with standard
The information on the carton and vial labels are not in the English language.
Conditions imposed
The 'Dear Healthcare Professional' letter identical to that provided to
the TGA by the company must be supplied with each dispensed unit of batch CK
2071 of the product.
The carton and vial labels for batch CK 2071 are identical to the
representative French product labels provided in the application. The main panel
of the carton label must be over-stickered with the over-label provided with the
application. #160;
The French package insert must be replaced with the Australian package
insert in each dispensed unit of batch CK 2071 of the product.
Therapeutic product type
Prescription medicines