National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) drugs and medicinal preparations (No. PB 61 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 61 of 2007

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsections 85 (2) and 85(2AA) of the National Health Act 1953.

Dated 14 August 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 September 2007.

2              Amendment of PB 48 of 2007

Schedule 1 amends PB 48 of 2007.

Schedule 1        Amendments

(section 2)

[1]           Schedule 1, after item dealing with Cephazolin

insert in the columns in the order indicated

Cetuximab	In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information
Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated

[2]          Schedule 1, item dealing with “Phenex-1”

omit from the columns in the order indicated

"Phenex-1" Phenylketonuria