National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 8 of 2009) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 8 of 2009
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) of the National Health Act 1953
I, ADRIANA PLATONA, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated 30 January 2009
ADRIANA PLATONA
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 March 2009.
2 Amendment of PB 113 of 2008
Schedule 1 amends PB 113 of 2008.
Schedule 1 Amendments
Schedule 1, after item dealing with Amlodipine with Atorvastatin
insert in the columns in the order indicated:
| Amlodipine with valsartan | Hypertension in patients who are not adequately controlled with either amlodipine or valsartan monotherapy |
Schedule 1, after item dealing with Ampicillin
insert in the columns in the order indicated:
| Amylopectin, modified long chain | Glycogen storage disease |
Schedule 1, item dealing with Bivalirudin
omit from the columns in the order indicated:
| 2147 | Patients undergoing non-emergency percutaneous coronary intervention |
and substitute:
| 3075 | A patient undergoing percutaneous coronary intervention |
Schedule 1, item dealing with Dasatinib
omit from “Column 3” under the heading “Chronic myeloid leukaemia”:
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or |
and substitute:
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or |
Schedule 1, after item dealing with Essential amino acids formula with minerals and vitamin C
insert in the columns in the order indicated:
| Essential amino acids formula with vitamins and minerals | Gyrate atrophy of the choroid and retina Urea cycle disorders |
Schedule 1, item dealing with Nilotinib
omit from “Column 3”:
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or |
and substitute:
| (iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or |
Schedule 1, after item dealing with Phenoxymethylpenicillin
insert in the columns in the order indicated:
| Phenylalanine with carbohydrate | Tyrosinaemia |
Schedule 1, item dealing with Risperidone
omit from “Column 2” the Streamlined authority code 2598 and the corresponding circumstances from “Column 3” (three instances) and substitute:
| 3083 | Treatment under the supervision of a paediatrician or psychiatrist, in combination with non-pharmacological measures, of severe behavioural disturbances in either a patient aged less than 18 years with autism, or a patient 18 years of age or older with autism who was commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age and is continuing PBS-subsidised treatment, where behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful, and where the diagnosis of autism has been made based on either the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or the ICD-10 international classification of mental and behavioural disorders |
Schedule 1, item dealing with Tacrolimus
omit all text from “Column 3” and substitute:
| In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy, following initiation and stabilisation of treatment with tacrolimus, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application |
Schedule 1, item dealing with Trandolapril with Verapamil
omit all text from “Column 3” and substitute:
| Hypertension in a patient who is not adequately controlled wih either trandolapril or verapamil hydrochloride sustained release monotherapy |
Schedule 1, item dealing with Triglycerides — medium chain, formula
insert as first circumstance in “Column 3”:
| In respect of the sachets containing oral powder 16 g, 25 (MCT Pro-Cal): In compliance with authority procedures set out in subparagraph 14 (d): Chylous ascites Chylothorax Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders Hyperlipoproteinaemia type 1 Long chain fatty acid oxidation disorders |
Schedule 1, after item dealing with Valproic Acid
insert in the columns in the order indicated:
| Valsartan | — |
| Valsartan with hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or valsartan monotherapy |
Schedule 1, after item dealing with Warfarin
insert in the columns in the order indicated:
| Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | In compliance with authority procedures set out in subparagraph 14 (d): Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet |
Schedule 2A, after item dealing with Aciclovir
insert in the columns in the order indicated:
| Betaxolol | ― |
| Bimatoprost | ― |
| Brimonidine | ― |
| Brimonidine with Timolol | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL |
| Brinzolamide | ― |
Schedule 2A, after item dealing with Cromoglycic Acid
insert in the columns in the order indicated:
| Dorzolamide | ― |
| Dorzolamide with Timolol | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL |
Schedule 2A, after item dealing with Hypromellose with Dextran
insert in the columns in the order indicated:
| Latanoprost | ― |
| Latanoprost with Timolol | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops |
Schedule 2A, after item dealing with Paraffin
insert in the columns in the order indicated:
| Pilocarpine | ― |
Schedule 2A, after item dealing with Tamarindus indica seed polysaccharide
insert in the columns in the order indicated:
| Timolol | ― |
| Travoprost | ― |
| Travoprost with Timolol | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops or travoprost eye drops Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL or latanoprost eye drops or travoprost eye drops |
Schedule 3, item dealing with Amlodipine
insert in “Column 2” after “Amlodipine with Atorvastatin”:
Amlodipine with Valsartan
Schedule 3, item dealing with Hydrochlorothiazide
insert in “Column 2” after “Telmisartan with Hydrochlorothiazide”:
Valsartan with Hydrochlorothiazide
Schedule 3, after item dealing with Trimethoprim
insert in the columns in the order indicated:
| Valsartan | Amlodipine with Valsartan Valsartan with Hydrochlorothiazide |
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