COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On October 15, 2013, 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”) gave his consent to:
(a) the supply of the products
- tolvaptan (SAMSCA) 15 mg tablet blister pack [Aust R 176602]
- tolvaptan (SAMSCA) 30 mg tablet blister pack [Aust R 176601]
by Aspen Pharma Pty Ltd, ST LEONARDS, NSW (“the Company”);
That do not conform with paragraphs 3(2)(1) of Therapeutic Goods Order (TGO) 69, in that the blister labels do not state the Australian sponsor.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The cartons are over-stickered with the warning statements “Prescription only medicine. Keep out of reach of children,” storage conditions, Australian sponsor’s details and the AUST R numbers;
- A ‘Dear Pharmacist’ letter, provided with the Company letter dated October 14, 2013, advising healthcare practitioners to instruct patients to keep the blisters in the cartons so that the Australian sponsor’s contact details are retained.
- No other changes have been made to:
- tolvaptan (SAMSCA) 15 mg tablet blister pack [Aust R 176602]
- tolvaptan (SAMSCA) 30 mg tablet blister pack [Aust R 176601]