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NPLATE romiplostim (rbe) 375 microgram powder for injection vial, Amgen Australia Pty Ltd, CON-363
Product name
NPLATE romiplostim (rbe) 375 microgram powder for injection vial
Sponsor name
Amgen Australia Pty Ltd
Consent start
Consent no.
CON-363
Standard
Subparagraph 11(2)(f)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The product labels do not express the quantity of active as the stated weight of
active ingredient of the vial. Instead, the quantity of active ingredient is
expressed in terms of concentration.
Conditions imposed
The products to which this consent applies are those specified in the request
submitted.
Therapeutic product type
Prescription medicines