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
Duration
The consent is effective from 5 February 2021 until batches 304451 and 308071 are depleted.
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”.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines