IDAPREX COMBI 4/1.25 perindopril erbumine 4 mg and indapamide hemihydrate 1.25 mg tablet blister pack, Servier Laboratories Australia Pty Ltd, CON-749
Product name
IDAPREX COMBI 4/1.25 perindopril erbumine 4 mg and indapamide hemihydrate 1.25 mg tablet blister pack
Sponsor name
Servier Laboratories Australia Pty Ltd
Batches
304451 308071
Consent start
Consent no.
CON-749
Standard
Subparagraphs 8(1)(j)(ii) and 8(1)(j)(iv)(A); and subsection 9(3) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform with the requirements of subparagraphs 8(1)(j)(ii)
and 8(1)(j)(iv)(A); and subsection 9(3) of Therapeutic Goods Order No. 91 '“
Standard for labels of prescription and related medicines in that the carton
label for the batches listed above include the lactose declaration as 'Contains
lactose' instead of 'Contains sugars as lactose'; and the name of the medicine
and the active ingredient do not appear as a cohesive unit on the carton main
panel as one of the active ingredients is followed by the text 'tablets'.
Therapeutic product type
Prescription medicines