THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On May 9, 2013 the delegate of the Secretary of the Department of Health and Ageing 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:
- phenytoin sandoz (PHENYTOIN SANDOZ) 100 mg/2 mL injection ampoule [Aust R 117872]
- phenytoin sandoz (PHENYTOIN SANDOZ) 250 mg/5 mL injection ampoule [Aust R 117865] by Sandoz Pty Ltd, Pyrmont, NSW (“the Company”);
That does not conform with paragraphs 3(2)(j), 3(5) and 3(11) of Therapeutic Goods Order (TGO) 69, in that the labels are the labels approved in Spain rather than the Australian approved labels.
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 consent applies to batch G01 of PHENYTOIN SANDOZ 100 mg/2 mL injection and batch G03 of PHENYTOIN SANDOZ 250 mg/5 mL injection.
2. The labels for use are those submitted with the Company’s application, viz the Spanish carton and ampoule labels, but with the over-sticker provided in the e-mail letter of May 9, 2013 on the carton label.
3. No other changes have been made to the products:
- phenytoin sandoz (PHENYTOIN SANDOZ) 100 mg/2 mL injection ampoule [Aust R 117872]
- phenytoin sandoz (PHENYTOIN SANDOZ) 250 mg/5 mL injection ampoule [Aust R 117865] by Sandoz Pty Ltd, Pyrmont, NSW (“the Company”);
4. Each pack of the products is to be supplied with the Australian product information (PI) together with the “Dear Doctor/Pharmacist/Healthcare Professional” letter provided in the e-mail letter of May 8, 2013.
5. The company will pay the normal fee that applies for an application to make this change.