COMMONWEALTH OF AUSTRALIA
Instrument number PB 69 of 2008
Amendment determination under section 84AH of the National Health Act 1953
I, ANDREW MITCHELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing make this instrument under section 84AH of the National Health Act 1953.
Dated 3 JUNE 2008
ANDREW MITCHELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination – exempt items
1 Commencement
This instrument commences on 1 July 2008.
2 Amendment of PB 58 of 2007
Schedule 1 amends PB 58 of 2007.
Schedule 1 Amendments
[1] Schedule 1, item dealing with Baclofen
omit from the columns in the order indicated:
| Baclofen | Injection 10 mg in 5 mL | Injection |
| Baclofen | Injection 10 mg in 20 mL | Injection |
[2] Schedule 1, item dealing with Cyclosporin
omit from the columns in the order indicated:
| Cyclosporin | Solution concentrate for intravenous infusion 250 mg in 5 mL | Injection |
[3] Schedule 1, item dealing with Hydrocortisone
omit from the columns in the order indicated:
| Hydrocortisone | Injection 100 mg (as sodium succinate) | Injection |
| Hydrocortisone | Injection 250 mg (as sodium succinate) | Injection |
[4] Schedule 1, after item dealing with Lansoprazole
insert in the columns in the order indicated:
| Levodopa with Carbidopa | Tablet 200 mg-50 mg (anhydrous) (modified release) | Oral |
[5] Schedule 1, item dealing with Metronidazole
omit from the columns in the order indicated:
| Metronidazole | Solution for intravenous infusion 500 mg in 100 mL | Injection |
[6] Schedule 1, item dealing with Octreotide
omit from the columns in the order indicated:
| Octreotide | Injection (modified release) 10 mg (as acetate) vial and diluent syringe | Injection |
| Octreotide | Injection (modified release) 20 mg (as acetate) vial and diluent syringe | Injection |
| Octreotide | Injection (modified release) 30 mg (as acetate) vial and diluent syringe | Injection |
[7] Schedule 1, after item dealing with Salbutamol, Oral solution 2 mg
(as sulfate) per 5 mL, 150 mL
insert in the columns in the order indicated:
| Salbutamol | Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Inhalation by mouth |