Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified by Astellas Pharma Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 9 April 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 Astellas Pharma Australia Pty Ltd, gave consent to the importation and supply of

• tacrolimus (PROGRAF-XL) 0.5 mg prolonged-release capsule blister pack [AUST R 158439]
• tacrolimus (PROGRAF-XL) 1 mg prolonged-release capsule blister pack [AUST R 158440]
• tacrolimus (PROGRAF-XL) 5 mg prolonged-release capsule blister pack [ AUST R 158444]
• tacrolimus (PROGRAF) 1 mg capsule blister pack [AUST R 58930]
• tacrolimus (PROGRAF) 5 mg capsule blister pack [AUST R 58931]
• tacrolimus (PROGRAF) 0.5 mg capsule blister pack [AUST R 77280]
• tacrolimus (PROGRAF) 5 mg/1 mL injection ampoule [AUST R 58932]

that does not conform with the requirements of subsection 3(2)(l), of the Therapeutic Goods Order 69 – General requirements for labels for medicines in that the labels state the previous sponsor details.

The consent is effective from 9 April 2015 until 31 March 2016.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels are those currently supplied which state the previous sponsor details.
2. Arrangements are in place to redirect all correspondence to the current sponsor (Astellas Pharma).
3. No other changes have been made to the product.