National Health Act 1953 - Amendment Determination under section 84AF - Responsible persons (No. PB 70 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L03613 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 70 OF 2007

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATION UNDER SECTION 84AF

 

 

Purpose and operation

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)).  These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.

Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item.  The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly.  The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.

A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act.  These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.

This instrument determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument.  These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN).  The names of the responsible persons were notified before the commencement of section 84AF as permitted by subsection 84AF(2). 

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 84AF made by legislative instrument number PB 50 of 2007 which came into effect on 1 August 2007.  The amendments are set out in the items of Schedule 1 to the instrument.

This instrument contains a number of changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 October 2007, was made on 6 September 2007.

Consultations

This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases.  This has occurred through meetings with both peak body organisations and individual companies.  Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item.  Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.

The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

ATTACHMENT

 

Paragraph 1: provides that this instrument commences on 1 October 2007.

Paragraph 2: provides that Schedule 1 amends PB 50 of 2007.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

 

Additions

 

Amisulpride   Tablet 100 g (Amisulpride Sandoz)

    Tablet 200 g (Amisulpride Sandoz)

    Tablet 400 g (Amisulpride Sandoz)

 

Fluconazole   Capsule 100 mg (Fluconazole Winthrop)

    Capsule 200 mg (Fluconazole Winthrop)

 

Insulin Glulisine  Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 (Apidra SoloStar)             

 

Irbesartan with  Tablet 300 mg-25 mg (Avapro HCT 300/25, Karvezide 300/25)

Hydrochlorothiazide

 

Oxaliplatin Solution concentrate for I.V. infusion 200 mg in 40 mL (Eloxatin)

 

Ramipril Capsule 10 mg (Tryzan 10)

 

  

Deletions

 

Glucose Indicator—Blood Electrode strips, 50 (GlucoMen Sensor)

 

Insulin Glulisine  Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 (Apidra)

 

Insulin Neutral with  Injection (human) 30 units-70 units per mL, 10 mL (Mixtard 30/70)

Insulin Isophane  Injection (human) 50 units-50 units per mL, 10 mL (Mixtard 50/50) 

Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5 (Mixtard 20/80 Penfill 3mL)

 

Lumiracoxib   Tablet 100 mg (Prexige)

 

Simvastatin    Tablet 5 mg (Lipex 5)

 

 

Alteration of Responsible Person

 

From:  Altana Pharma Pty Ltd   

 

To:   Nycomed Pty Ltd

Alterations of Listed Drug

 

From:

Aluminium Hydroxide - Dried with Magnesium Hydroxide

 

To:

Aluminium Hydroxide with Magnesium Hydroxide

 

 

From:

Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide

 

To:

Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide

 

 

 

Alterations of Form

 

Bleomycin

 

From:

Powder for injection containing bleomycin sulfate 15,000 I.U. (with required solvent)

 

To:

Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)

 

 

Cefepime

 

From:

Powder for injection 1 g (as hydrochloride) (with required solvent)

 

To:

Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

 

 

 

From:

Powder for injection 2 g (as hydrochloride) (with required solvent)

 

To:

Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

 

 

Cyclophosphamide

 

From:

Powder for injection 1 g (anhydrous) (with required solvent)

 

To:

Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

 

 

 

From:

Powder for injection 2 g (anhydrous) (with required solvent)

 

 

To:

Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

 

 

From:

Powder for injection 500 mg (anhydrous) (with required solvent)

 

 

To:

Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

 

 


Electrolyte Replacement, Solution

 

From:

Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per

 

 

To:

Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L

 

 

Esomeprazole and Clarithromycin and Amoxycillin

 

From:

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin

 

 

To:

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)

 

 

Metoprolol

 

From:

Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol

 

 

To:

Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release)

 

 

Oestradiol and Oestradiol with Norethisterone

 

From:

Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone

 

 

To:

Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate

 

 

From:

Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone

 

 

To:

Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate

 

 

Prochlorperazine

 

From:

Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5

 

 

To:

Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5

 

 

From:

Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5

 

 

To:

Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5

 

 

Sodium Lactate Compound

 

From:

I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as

 

 

To:

I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L

 

 

Testosterone

 

From:

Injection_containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in

 

 

To:

Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in 1 mL

 

 

Ticarcillin with Clavulanic Acid

 

From:

Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with required solvent)

 

 

To:

Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent)

 

 

Alterations of Listed Drug and Form

 

From:

 

“Alfaré”

Oral powder 400 g

To:

 

Protein hydrolysate

formula with medium

chain triglycerides

 

Oral powder 400 g (Alfaré)

From:

 

Calcium Folinate

Injection equivalent to 50 mg folinic acid in 5 mL

To:

 

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

 

From:

 

Calcium Folinate

Injection equivalent to 100 mg folinic acid in 10 mL

To:

 

Folinic acid

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

 

From:

 

Calcium Folinate

Injection equivalent to 300 mg folinic acid in 30 mL

To:

 

Folinic acid

Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

 

From:

 

Calcium Folinate

Tablet equivalent to 15 mg folinic acid

To:

 

Folinic acid

Tablet containing calcium folinate equivalent to 15 mg folinic acid

 

From:

 

“Caprilon”

Oral powder 420 g

To:

 

Triglycerides — medium

chain, formula

 

Oral powder 420 g (Caprilon)

From:

 

“Carbohydrate Free

Mixture”

Oral powder 225 g

To:

 

Milk protein and fat

formula with vitamins and

minerals — carbohydrate

free

 

Oral powder 225 g (Carbohydrate Free Mixture)

From:

 

“Dialamine”

Oral powder 200 g

To:

 

Essential amino acids

formula with minerals and

vitamin C

 

Oral powder 200 g (Dialamine)

From:

 

“Digestelact”

Oral powder 900 g

To:

 

Milk powder — lactose

modified

 

Oral powder 900 g (Digestelact)

From:

 

Diphtheria and Tetanus

Vaccine — Adsorbed

Injection 0.5 mL ampoule

To:

 

Diphtheria and tetanus

vaccine, adsorbed

 

Injection 0.5 mL

 

From:

 

Diphtheria and Tetanus

Vaccine — Adsorbed

(Diluted)

Injection 0.5 mL in pre-filled syringe

To:

 

Diphtheria and tetanus

vaccine, adsorbed,

diluted for adult use

 

Injection 0.5 mL in pre-filled syringe

 

From:

 

“Duocal”

Oral powder 400 g

To:

 

Triglycerides, medium

chain and long chain with

glucose polymer

 

Oral powder 400 g (Duocal)

From:

 

“Easiphen”

Oral liquid 250 mL

To:

 

Amino acid formula with

vitamins and minerals

without phenylalanine

 

Oral liquid 250 mL (Easiphen)

 

From:

 

“EleCare”

Oral powder 400 g

To:

 

Amino acids — synthetic,

Formula

 

Oral powder 400 g (EleCare)

 

From:

 

“Energivit”

Oral powder 400 g

To:

 

Carbohydrate, fat,

vitamins, minerals and

trace elements

 

Oral powder 400 g (Energivit)

From:

 

“HCU gel”

Sachets containing oral powder 20 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without methionine

 

Sachets containing oral powder 20 g, 30 (HCU gel)

From:

 

“HCU express”

Sachets containing oral powder 25 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without methionine

 

Sachets containing oral powder 25 g, 30 (HCU express)

From:

 

“Karicare De-Lact”

Oral powder 900 g

To:

 

Milk powder — lactose

free formula

 

Oral powder 900 g (Karicare De-Lact)

From:

 

“Ketonex-1”

Oral powder 350 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 350 g (Ketonex-1)


From:

 

“Ketonex-2”

Oral powder 325 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 325 g (Ketonex-2)

From:

 

“Kindergen”

Oral powder 400 g

To:

 

Whey protein formula

supplemented with

amino acids, vitamins and

minerals, and low in

protein, phosphate,

potassium and lactose

 

Oral powder 400 g (Kindergen)

From:

 

“Locasol”

Low calcium compound powder 400 g

To:

 

Milk powder — synthetic

 

Low calcium oral powder 400 g (Locasol)

From:

 

“Lophlex”

Sachets containing oral powder 27.8 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Sachets containing oral powder 27.8 g, 30 (Lophlex)

From:

 

“Lophlex LQ”

Oral liquid 125 mL, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral liquid 125 mL, 30 (Lophlex LQ)

From:

 

“Mapleflex”

Sachets containing oral powder 29 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Sachets containing oral powder 29 g, 30 (Mapleflex)

From:

 

“Metabolic Mineral

Mixture”

Oral powder 250 g

To:

 

Mineral mixture

 

Oral powder 250 g (Metabolic Mineral Mixture)


From:

 

“Minaphlex”

Sachets containing oral powder 29 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Sachets containing oral powder 29 g, 30 (Minaphlex)

From:

 

“Monogen”

Oral powder 400 g

To:

 

Triglycerides — medium

chain, formula

 

Oral powder 400 g (Monogen)

From:

 

“MSUD AID III”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 500 g (MSUD AID III)

From:

 

“MSUD Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 400 g (MSUD Analog)

From:

 

“MSUD Express”

Sachets containing oral powder 25 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Sachets containing oral powder 25 g, 30 (MSUD Express)

From:

 

“MSUD Express Cooler”

Oral liquid 130 mL, 30

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral liquid 130 mL, 30 (MSUD Express Cooler)

From:

 

“MSUD-gel”

Sachets containing oral powder 20 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Sachets containing oral powder 20 g, 30 (MSUD-gel)


From:

 

“MSUD Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 500 g (MSUD Maxamaid)

From:

 

“MSUD Maxamum”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without valine, leucine

and isoleucine

 

Oral powder 500 g (MSUD Maxamum)

From:

 

“Neocate”

Oral powder 400 g

To:

 

Amino acids — synthetic,

Formula

 

Oral powder 400 g (Neocate)

From:

 

“Neocate Advance”

Oral powder 400 g

To:

 

Amino acids — synthetic,

formula

 

Oral powder 400 g (Neocate Advance)

From:

 

“Neocate Advance

Tropical Flavour”

Oral powder 400 g

To:

 

Amino acids — synthetic,

formula

 

Oral powder 400 g (Neocate Advance Tropical Flavour)

From:

 

“Neocate LCP”

Oral powder 400 g

To:

 

Amino acid synthetic

formula supplemented with

long chain polyunsaturated

fatty acids

 

Oral powder 400 g (Neocate LCP)

From:

 

“Pepti-Junior”

Oral powder 450 g

To:

 

Protein hydrolysate

formula with medium

chain triglycerides

 

Oral powder 450 g (Pepti-Junior)


From:

 

“Phenex-2”

Oral powder 325 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral powder 325 g (Phenex-2)

From:

 

“Phenex-2”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral powder 400 g (Phenex-2)

From:

 

“Phlexy-10”

Capsules 500 mg, 200

To:

 

Amino acid formula

without phenylalanine

 

Capsules 500 mg, 200 (Phlexy-10)

From:

 

“Phlexy-10”

Tablets 1 g, 75

To:

 

Amino acid formula

without phenylalanine

 

Tablets 1 g, 75 (Phlexy-10)

From:

 

“Phlexy-10”

Bars 42 g, 20

To:

 

Amino acid formula

without phenylalanine

 

Bars 42 g, 20 (Phlexy-10)

From:

 

“Phlexy-10 Drink Mix”

Sachets containing oral powder 20 g, 30

To:

 

Amino acid formula

without phenylalanine

 

Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)

From:

 

“PK AID II”

Oral powder 250 g

To:

 

Amino acid formula

without phenylalanine

 

Oral powder 250 g (PK AID II)

From:

 

“PKU Cooler 10”

Oral liquid 87 mL, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral liquid 87 mL, 30 (PKU Cooler 10)


From:

 

“PKU Cooler 15”

Oral liquid 130 mL, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral liquid 130 mL, 30 (PKU Cooler 15)

From:

 

“PKU Cooler 20”

Oral liquid 174 mL, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral liquid 174 mL, 30 (PKU Cooler 20)

From:

 

“PKU-Express”

Sachets containing oral powder 25 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Sachets containing oral powder 25 g, 30 (PKU-Express)

From:

 

“PKU-gel”

Sachets containing oral powder 20 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Sachets containing oral powder 20 g, 30 (PKU-gel)

From:

 

“Pro-Phree”

Oral powder 400 g

To:

 

Carbohydrate, fat,

vitamins, minerals and

trace elements

 

Oral powder 400 g (Pro-Phree)

From:

 

“RCF”

Oral liquid 384 mL

To:

 

Soy protein and fat

formula with vitamins and

minerals — carbohydrate

free

 

Oral liquid 384 mL (RCF)

From:

 

“S-26 LF”

Infant formula powder 900 g

To:

 

Milk powder — lactose

free formula

 

Oral powder 900 g (S-26 LF)


From:

 

Sodium Alginate with

Calcium Carbonate and 

Sodium Bicarbonate

Oral liquid 1 g-320 mg-534 mg in 20 mL, 500 mL

To:

 

Alginic acid with calcium

carbonate and sodium

bicarbonate

 

Oral liquid containing alginic acid as sodium alginate 1 g, calcium carbonate 320 mg and sodium bicarbonate 534 mg in 20 mL, 500 mL

From:

 

Triglycerides Oil —

Medium Chain

500 mL

To:

 

Triglycerides, medium

Chain

 

Oil 500 mL (MCT Oil)

 

From:

 

“TYR gel”

Sachets containing oral powder 20 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine and

tyrosine

 

Sachets containing oral powder 20 g, 30 (TYR gel)

From:

 

“TYR Express”

Sachets containing oral powder 25 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine and

tyrosine

 

Sachets containing oral powder 25 g, 30 (TYR Express)

From:

 

“XLYS, LOW TRY

Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without lysine and low in

tryptophan

 

Oral powder 400 g (XLYS, LOW TRY Analog)

From:

 

“XLYS, LOW TRY

Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without lysine and low in

tryptophan

 

Oral powder 500 g (XLYS, LOW TRY Maxamaid)


From:

 

“XMET Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine

 

Oral powder 400 g (XMET Analog)

From:

 

“XMET Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine

 

Oral powder 500 g (XMET Maxamaid)

From:

 

“XMET Maxamum”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine

 

Oral powder 500 g (XMET Maxamum)

From:

 

“XMTVI Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine,

threonine and valine and

low in isoleucine

 

Oral powder 400 g (XMTVI Analog)

From:

 

XMTVI Asadon

Oral powder 200 g

To:

 

Amino acid formula

without methionine,

threonine and valine and

low in isoleucine

 

Oral powder 200 g (XMTVI Asadon)

From:

 

“XMTVI Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine,

threonine and valine and

low in isoleucine

 

Oral powder 500 g (XMTVI Maxamaid)


From:

 

“XMTVI Maxamum”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without methionine,

threonine and valine and

low in isoleucine

 

Oral powder 500 g (XMTVI Maxamum)

From:

 

“XP Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral powder 400 g (XP Analog)

From:

 

“XP Analog LCP”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins, minerals

and long chain

polyunsaturated fatty acids

without phenylalanine

 

Oral powder 400 g (XP Analog LCP)

From:

 

“XPhen, Tyr Analog”

Oral powder 400 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine and

tyrosine

 

Oral powder 400 g (XPhen, Tyr Analog)

From:

 

“XPhen, Tyr Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine and

tyrosine

 

Oral powder 500 g (XPhen, Tyr Maxamaid)

From:

 

“XPhen, Tyr Maxamum”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine and

tyrosine

 

Oral powder 500 g (XPhen, Tyr Maxamum)


From:

 

“XP Maxamaid”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral powder 500 g (XP Maxamaid)

From:

 

“XP Maxamum”

Oral powder 500 g

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Oral powder 500 g (XP Maxamum)

From:

 

“XP Maxamum”

Sachets containing oral powder 50 g, 30

To:

 

Amino acid formula

with vitamins and minerals

without phenylalanine

 

Sachets containing oral powder 50 g, 30 (XP Maxamum)

From:

 

“XPTM Tyrosidon”

Oral powder 500 g

To:

 

Amino acid formula

without phenylalanine,

tyrosine and methionine

 

Oral powder 500 g (XPTM Tyrosidon)

 

 

 

Interactions

Authorises

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.