Elevit Film Coated Tablet, Bayer Australia Ltd, CON-186
Product name
Elevit Film Coated Tablet
Sponsor name
Bayer Australia Ltd
Consent start
Consent no.
CON-186
Standard
Sections 11(a), 11(b) and 11(c) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO78)
Non-compliance with standard
Section 11(a) of the (TGO 78) requires that a registered tablet or capsule
without an individual British Pharmacopoeia (BP) monograph must comply with the
test for Uniformity of Dosage Units of the BP, in the general monographs
'Tablets' or 'Capsules', respectively. With respect to a registered tablet or
capsule without an individual BP monograph, section 11(b), TGO 78 requires that
the average content of each active ingredient in a pooled sample of not fewer
than 20 tablets or capsules must be not less than 92.5% and not more than 107.5%
of the stated content of that active ingredient. With respect to section 11(c),
TGO 78 requires that a registered tablet or capsule without an individual BP
monograph must comply with a suitable test for dissolution that demonstrates the
appropriate release of each active ingredient for which the BP or United States
Pharmacopeia-National Formulary (USP-NF) includes an individual monograph for a
tablet or capsule and requires a test for dissolution.
Conditions imposed
1. The goods are not required to comply with TGO 78 section 11(a) but must
comply with the requirements of the British Pharmacopoeia Appendix XII C
Uniformity of Weight (Mass).2. The goods are not required to comply with TGO 78
section 11(b) but the average content of each active ingredient in the goods
must comply with the relevant acceptance criteria included in Attachment 2.3.
The goods are not required to comply with TGO 78 section 11(c) but must comply
with the dissolution requirements of the United States Pharmacopeia-National
Formulary, Dietary Supplement Chapter 2040 'Disintegration and Dissolution of
Dietary Supplements' for riboflavine (Vitamin B2) and iron as set out in
Attachment 2.
Therapeutic product type
Over-the-counter medicines