Prolastin-C alpha1- proteinase inhibitor (human) 1000 mg powder for injection vial with diluent vial, Grifols Australia Pty Ltd, CON-343
Product name
Prolastin-C alpha1- proteinase inhibitor (human) 1000 mg powder for injection vial with diluent vial
Sponsor name
Grifols Australia Pty Ltd
ARTG
234553
Consent start
Consent no.
CON-343
Standard
Subparagraph 7(5)(b)(i) of the Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO No. 69)
Non-compliance with standard
The product labels do not include the name and quantity of each excipient in the
goods.
Therapeutic product type
Prescription medicines