COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 26 May 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 supply of
- brentuximab vedotin (rch) (ADCETRIS) 50 mg powder for injection vial [AUST R 203372]
that does not conform with the requirements of subsections 3(2)(j), 3(2)(k), 3(2)(l) and 3(5)(c), of the Therapeutic Goods Order No 69 – General requirements for labels for medicines (TGO 69), in that storage conditions, direction for use, the name, the address of the Sponsor and the following text is included on the outer carton but omitted on the vial label.
“For intravenous use after reconstitution and dilution, Don’t administer the reconstituted solution undiluted. Refer to the enclosed package.”
The consent is effective from 26 May 2015 until 31 May 2017.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- That ADCETRIS vial will be supplied in a sealed tamper evidence outer carton that contains all the information required to meet TGO 69 requirements and to support the safe and effective use of ADCETRIS.
2. That additional text as the storage conditions, direction for use, the name, the address of the sponsor and the following text will be included on the outer carton to make it clear to the reader.
3. That product information will be included as pack insert, as required for all injectable medicines.
“For intravenous use after reconstitution and dilution, don’t administers the reconstituted solution undiluted. Refer to the enclosed package.”
4. That labels to which this consent applies are those previously approved and arrangements are in place for the prompt referral of any queries or complaints concerning the product.