COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 January 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Takeda Pharmaceuticals Australia Pty Ltd, gave consent to the importation and supply of
- pioglitazone (ACTOS) 15 mg (as hydrochloride) tablet - uncoated blister pack [AUST R 76462]
- pioglitazone (ACTOS) 30 mg (as hydrochloride) tablet - uncoated blister pack [AUST R 76463]
- pioglitazone (ACTOS) 45 mg (as hydrochloride) tablet - uncoated blister pack [AUST R 76464]
that does not conform with the requirements of paragraph 3(2)(l) and 3(13)(a) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines, in that the name, logo and address of the previous sponsor (Eli Lilly Australia Pty Ltd) is stated instead of the current sponsor (Takeda).
The consent is effective from the date of this letter until the batches specified below are exhausted.
Product | AUST R | Batch No. |
ACTOS 15mg tablets | 76462 | C227278, C239210, C246399, C345100 |
ACTOS 30mg tablets | 76463 | C183494, C347707, C354440 |
ACTOS 45mg tablets | 76464 | C203823, C229062, C240405, C295938A, C356884 |
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor Eli Lilly Australia Pty Ltd.
- Arrangements are in place with the former sponsor Eli Lilly Australia Pty Ltd for the prompt referral of any correspondence concerning the products to Takeda Pharmaceuticals Australia Pty Ltd.
- No other changes have been made.