National Health Act 1953 - Amendment Determinations under sections 85, 85a and 88 - Pharmaceutical benefits (No. PB 69 of 2007) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 69 of 2007
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 6 Sept 2007
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination — pharmaceutical benefits
1 Commencement
This instrument commences on 1 October 2007.
2 Amendment of PB 49 of 2007
Schedule 1 amends PB 49 of 2007.
Schedule 1 Amendments
(section 2)
[1] Part 1 of Schedule 1, after item dealing with Alendronic Acid with Colecalciferol
insert in the columns in the order indicated:
| 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 | Oral | 2 | 5 | Gaviscon P |
[2] Part 1 of Schedule 1, omit item dealing with “Alfaré”
[3] Part 1 of Schedule 1, after item dealing with Amiloride
insert in the columns in the order indicated:
| Amino acid formula without methionine, threonine and valine and low in isoleucine | Oral powder 200 g (XMTVI Asadon) | Oral | 5 | 5 | XMTVI Asadon |
| Amino acid formula without phenylalanine | Capsules 500 mg, 200 (Phlexy-10) | Oral | 16 | 5 | Phlexy-10 |
| Tablets 1 g, 75 (Phlexy-10) | Oral | 24 | 5 | Phlexy-10 | |
| Bars 42 g, 20 (Phlexy-10) | Oral | 10 | 5 | Phlexy-10 | |
| Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix) | Oral | 7 | 5 | Phlexy-10 Drink Mix | |
| Oral powder 250 g (PK AID II) | Oral | 8 | 5 | PK AID II | |
| Amino acid formula without phenylalanine, tyrosine and methionine | Oral powder 500 g (XPTM Tyrosidon) | Oral | 4 | 5 | XPTM Tyrosidon |
| Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | Oral powder 400 g (XP Analog LCP) | Oral | 8 | 5 | XP Analog LCP |
| Amino acid formula with vitamins and minerals without lysine and low in tryptophan | Oral powder 400 g (XLYS, LOW TRY Analog) | Oral | 8 | 5 | XLYS, LOW TRY Analog |
| Oral powder 500 g (XLYS, LOW TRY Maxamaid) | Oral | 8 | 5 | XLYS, LOW TRY Maxamaid | |
| Amino acid formula with vitamins and minerals without methionine | Oral powder 400 g (XMET Analog) | Oral | 8 | 5 | XMET Analog |
| Sachets containing oral powder 20 g, 30 (HCU gel) | Oral | 4 | 5 | HCU gel | |
| Sachets containing oral powder 25 g, 30 (HCU express) | Oral | 4 | 5 | HCU express | |
| Oral powder 500 g (XMET Maxamaid) | Oral | 8 | 5 | XMET Maxamaid | |
| Oral powder 500 g (XMET Maxamum) | Oral | 8 | 5 | XMET Maxamum | |
| Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | Oral powder 400 g (XMTVI Analog) | Oral | 8 | 5 | XMTVI Analog |
| Oral powder 500 g (XMTVI Maxamaid) | Oral | 8 | 5 | XMTVI Maxamaid | |
| Oral powder 500 g (XMTVI Maxamum) | Oral | 8 | 5 | XMTVI Maxamum | |
| Amino acid formula with vitamins and minerals without phenylalanine | Sachets containing oral powder 20 g, 30 (PKU-gel) | Oral | 4 | 5 | PKU-gel |
| Sachets containing oral powder 25 g, 30 (PKU-Express) | Oral | 4 | 5 | PKU-Express | |
| Sachets containing oral powder 27.8 g, 30 (Lophlex) | Oral | 3 | 5 | Lophlex | |
| Sachets containing oral powder 29 g, 30 (Minaphlex) | Oral | 4 | 5 | Minaphlex | |
| Sachets containing oral powder 50 g, 30 (XP Maxamum) | Oral | 3 | 5 | XP Maxamum | |
| Oral powder 400 g (XP Analog) | Oral | 8 | 5 | XP Analog | |
| Oral powder 325 g (Phenex-2) | Oral | 10 | 5 | Phenex-2 | |
| Oral powder 400 g (Phenex-2) | Oral | 8 | 5 | Phenex-2 | |
| Oral powder 500 g (XP Maxamaid) | Oral | 8 | 5 | XP Maxamaid | |
| Oral powder 500 g (XP Maxamum) | Oral | 8 | 5 | XP Maxamum | |
| Oral liquid 250 mL (Easiphen) | Oral | 90 | 5 | Easiphen | |
| Oral liquid 87 mL, 30 (PKU Cooler 10) | Oral | 4 | 5 | PKU Cooler 10 | |
| Oral liquid 125 mL, 30 (Lophlex LQ) | Oral | 3 | 5 | Lophlex LQ | |
| Oral liquid 130 mL, 30 (PKU Cooler 15) | Oral | 4 | 5 | PKU Cooler 15 | |
| Oral liquid 174 mL, 30 (PKU Cooler 20) | Oral | 4 | 5 | PKU Cooler 20 | |
| Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Sachets containing oral powder 20 g, 30 (TYR gel) | Oral | 4 | 5 | TYR gel |
| Sachets containing oral powder 25 g, 30 (TYR Express) | Oral | 4 | 5 | TYR Express | |
| Oral powder 400 g (XPhen, Tyr Analog) | Oral | 8 | 5 | XPhen, Tyr Analog | |
| Oral powder 500 g (XPhen, Tyr Maxamaid) | Oral | 8 | 5 | XPhen, Tyr Maxamaid | |
| Oral powder 500 g (XPhen, Tyr Maxamum) | Oral | 8 | 5 | XPhen, Tyr Maxamum | |
| Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Sachets containing oral powder 20 g, 30 (MSUD-gel) | Oral | 4 | 5 | MSUD-gel |
| Sachets containing oral powder 25 g, 30 (MSUD Express) | Oral | 4 | 5 | MSUD Express | |
| Sachets containing oral powder 29 g, 30 (Mapleflex) | Oral | 4 | 5 | Mapleflex | |
| Oral powder 350 g (Ketonex-1) | Oral | 8 | 5 | Ketonex-1 | |
| Oral powder 400 g (MSUD Analog) | Oral | 8 | 5 | MSUD Analog | |
| Oral powder 325 g (Ketonex-2) | Oral | 10 | 5 | Ketonex-2 | |
| Oral powder 500 g (MSUD AID III) | Oral | 4 | 5 | MSUD AID III | |
| Oral powder 500 g (MSUD Maxamaid) | Oral | 8 | 5 | MSUD Maxamaid | |
| Oral powder 500 g (MSUD Maxamum) | Oral | 8 | 5 | MSUD Maxamum | |
| Oral liquid 130 mL, 30 (MSUD Express Cooler) | Oral | 4 | 5 | MSUD Express Cooler | |
| Amino acids — synthetic, formula | Oral powder 400 g (EleCare) | Oral | 8 | 5 | EleCare |
| Oral powder 400 g (Neocate) | Oral | 8 | 5 | Neocate | |
| Oral powder 400 g (Neocate Advance) | Oral | 8 | 5 | Neocate Advance | |
| Oral powder 400 g (Neocate Advance Tropical Flavour) | Oral | 8 | 5 | Neocate Advance Tropical Flavour | |
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) | Oral | 8 | 5 | Neocate LCP |
[4] Part 1 of Schedule 1, item dealing with Amisulpride
(a) in the form Tablet 100 mg
in the column headed “Brand” insert:
Amisulpride Sandoz
after:
Amisulpride 100 Winthrop
(b) in the form Tablet 200 mg
in the column headed “Brand” insert:
Amisulpride Sandoz
after:
Amisulpride 200 Winthrop
(c) in the form Tablet 400 mg
in the column headed “Brand” insert:
Amisulpride Sandoz
after:
Amisulpride 400 Winthrop
[5] Part 1 of Schedule 1, omit item dealing with Calcium Folinate
[6] Part 1 of Schedule 1, omit item dealing with “Caprilon”
[7] Part 1 of Schedule 1, after item dealing with Carbimazole
insert in the columns in the order indicated:
| Carbohydrate, fat, vitamins, minerals and trace elements | Oral powder 400 g (Pro-Phree) | Oral | 8 | 5 | Pro-Phree |
| Oral powder 400 g (Energivit) | Oral | 8 | 5 | Energivit |
[8] Part 1 of Schedule 1, omit item dealing with “Carbohydrate Free Mixture”
[9] Part 1 of Schedule 1, omit item dealing with “Dialamine”
[10] Part 1 of Schedule 1, omit item dealing with “Digestelact”
[11] Part 1 of Schedule 1, after item dealing with Diphenoxylate with Atropine
insert in the columns in the order indicated:
| Diphtheria and tetanus vaccine, adsorbed | Injection 0.5 mL | Injection | 3 | . . | Aspen Pharmacare Australia Pty Ltd |
| Diphtheria and tetanus vaccine, adsorbed, diluted for adult use | Injection 0.5 mL in pre-filled syringe | Injection | 5 | . . | ADT Booster |
[12] Part 1 of Schedule 1, omit item dealing with Diphtheria and Tetanus Vaccine – Adsorbed
[13] Part 1 of Schedule 1, omit item dealing with Diphtheria and Tetanus Vaccine – Adsorbed (Diluted)
[14] Part 1 of Schedule 1, omit item dealing with “Duocal”
[15] Part 1 of Schedule 1, omit item dealing with “Easiphen”
[16] Part 1 of Schedule 1, omit item dealing with “EleCare”
[17] Part 1 of Schedule 1, omit item dealing with “Energivit”
[18] Part 1 of Schedule 1, after item dealing with Esomeprazole and Clarithromycin and Amoxycillin
insert in the columns in the order indicated:
| Essential amino acids formula with minerals and vitamin C | Oral powder 200 g (Dialamine) | Oral | 10 | 5 | Dialamine |
[19] Part 1 of Schedule 1, item dealing with Fluconazole
(a) in the form Capsule 100 mg
in the column headed “Brand” insert:
Fluconazole Winthrop
after:
Fluconazole Hexal
(b) in the form Capsule 200 mg
in the column headed “Brand” insert:
Fluconazole Winthrop
after:
Fluconazole Hexal
[20] Part 1 of Schedule 1, after item dealing with Folic Acid
insert in the columns in the order indicated:
| Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid | Oral | 10 | . . | Leucovorin Calcium (Mayne Pharma Pty Ltd) |
| Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Injection | 5 | 5 | Calcium Folinate Ebewe Leucovorin Calcium (Mayne Pharma Pty Ltd) Leucovorin Calcium (Pfizer Pty Limited) | |
| Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Injection | 10 | 1 | Calcium Folinate Ebewe Leucovorin Calcium (Pfizer Pty Limited) | |
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | 4 | 1 | Leucovorin Calcium (Mayne Pharma Pty Ltd) |
[21] Part 1 of Schedule 1, item dealing with Glucose Indicator – Blood
omit from the columns in the order indicated:
| Electrode strips, 50 (GlucoMen Sensor) | For external use | 2 | 5 | GlucoMen Sensor |
[22] Part 1 of Schedule 1, omit item dealing with “HCU express”
[23] Part 1 of Schedule 1, omit item dealing with “HCU gel”
[24] Part 1 of Schedule 1, item dealing with Insulin Glulisine in the form Injection (human analogue), cartridges,
100 units per mL, 3 mL, 5
omit from the column headed “Brand”:
Apidra
and substitute:
Apidra SoloStar
[25] Part 1 of Schedule 1, item dealing with Insulin Neutral with Insulin Isophane in the form Injection (human)
30 units-70 units per mL, 10 mL
omit from the column headed “Brand”:
Mixtard 30/70
[26] Part 1 of Schedule 1, item dealing with Insulin Neutral with Insulin Isophane
omit from the columns in the order indicated:
| Injection (human) 50 units-50 units per mL, 10 mL | Injection | 5 | 2 | Mixtard 50/50 |
| Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5 | Injection | 5 | 1 | Mixtard 20/80 Penfill 3 mL |
[27] Part 1 of Schedule 1, after item dealing with Irbesartan with Hydrochlorothiazide in the form
Tablet 300 mg-12.5 mg
insert in the columns in the order indicated:
| Tablet 300 mg-25 mg | Oral | 30 | 5 | Avapro HCT 300/25 Karvezide 300/25 |
[28] Part 1 of Schedule 1, omit item dealing with “Karicare De-Lact”
[29] Part 1 of Schedule 1, omit item dealing with “Ketonex-1”
[30] Part 1 of Schedule 1, omit item dealing with “Ketonex-2”
[31] Part 1 of Schedule 1, omit item dealing with “Kindergen”
[32] Part 1 of Schedule 1, omit item dealing with “Locasol”
[33] Part 1 of Schedule 1, omit item dealing with “Lophlex”
[34] Part 1 of Schedule 1, omit item dealing with “Lophlex LQ”
[35] Part 1 of Schedule 1, omit item dealing with Lumiracoxib
[36] Part 1 of Schedule 1, omit item dealing with “Mapleflex”
[37] Part 1 of Schedule 1, omit item dealing with “Metabolic Mineral Mixture”
[38] Part 1 of Schedule 1, after item dealing with Miconazole
insert in the columns in the order indicated:
| Milk powder — lactose free formula | Oral powder 900 g (S-26 LF) | Oral | 5 | . . | S-26 LF |
| Oral powder 900 g (Karicare De-Lact) | Oral | 5 | . . | Karicare De-Lact | |
| Milk powder — lactose modified | Oral powder 900 g (Digestelact) | Oral | 3 | 1 | Digestelact |
| Milk powder — synthetic | Low calcium oral powder 400 g (Locasol) | Oral | 8 | 5 | Locasol |
| Milk protein and fat formula with vitamins and minerals — carbohydrate free | Oral powder 225 g (Carbohydrate Free Mixture) | Oral | 24 | 5 | Carbohydrate Free Mixture |
| Mineral mixture | Oral powder 250 g (Metabolic Mineral Mixture) | Oral | 1 | 5 | Metabolic Mineral Mixture |
[39] Part 1 of Schedule 1, omit item dealing with “Minaphlex”
[40] Part 1 of Schedule 1, omit item dealing with “Monogen”
[41] Part 1 of Schedule 1, omit item dealing with “MSUD AID III”
[42] Part 1 of Schedule 1, omit item dealing with “MSUD Analog”
[43] Part 1 of Schedule 1, omit item dealing with “MSUD Express”
[44] Part 1 of Schedule 1, omit item dealing with “MSUD Express Cooler”
[45] Part 1 of Schedule 1, omit item dealing with “MSUD-gel”
[46] Part 1 of Schedule 1, omit item dealing with “MSUD Maxamaid”
[47] Part 1 of Schedule 1, omit item dealing with “MSUD Maxamum”
[48] Part 1 of Schedule 1, omit item dealing with “Neocate”
[49] Part 1 of Schedule 1, omit item dealing with “Neocate Advance”
[50] Part 1 of Schedule 1, omit item dealing with “Neocate Advance Tropical Flavour”
[51] Part 1 of Schedule 1, omit item dealing with “Neocate LCP”
[52] Part 1 of Schedule 1, after item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg
insert in the columns in the order indicated:
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | 1 | 2 | Eloxatin |
[53] Part 1 of Schedule 1, omit item dealing with “Pepti-Junior”
[54] Part 1 of Schedule 1, omit item dealing with “Phenex-2”
[55] Part 1 of Schedule 1, omit item dealing with “Phlexy-10”
[56] Part 1 of Schedule 1, omit item dealing with “Phlexy-10 Drink Mix”
[57] Part 1 of Schedule 1, omit item dealing with “PK AID II”
[58] Part 1 of Schedule 1, omit item dealing with “PKU Cooler 10”
[59] Part 1 of Schedule 1, omit item dealing with “PKU Cooler 15”
[60] Part 1 of Schedule 1, omit item dealing with “PKU Cooler 20”
[61] Part 1 of Schedule 1, omit item dealing with “PKU-Express”
[62] Part 1 of Schedule 1, omit item dealing with “PKU-gel”
[63] Part 1 of Schedule 1, item dealing with Prochlorperazine
omit from the column headed “Form (strength, type, size, etc.)”:
| Suppositories, 3 mg, equivalent to 5 mg prochlorperazine maleate, 5 |
| Suppositories, 15 mg, equivalent to 25 mg prochlorperazine maleate, 5 |
and substitute:
| Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 |
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 |
[64] Part 1 of Schedule 1, omit item dealing with “Pro-Phree”
[65] Part 1 of Schedule 1, after item dealing with Propylthiouracil
insert in the columns in the order indicated:
| Protein hydrolysate formula with medium chain triglycerides | Oral powder 400 g (Alfaré) | Oral | 8 | 5 | Alfaré |
| Oral powder 450 g (Pepti-Junior) | Oral | 8 | 5 | Pepti-Junior |
[66] Part 1 of Schedule 1, item dealing with Ramipril in the form Capsule 10 mg
in the column headed “Brand” insert:
Tryzan 10
after:
Tritace 10 mg
[67] Part 1 of Schedule 1, omit item dealing with “RCF”
[68] Part 1 of Schedule 1, omit item dealing with “S-26 LF”
[69] Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 5 mg
omit from the column headed “Brand”:
Lipex 5
[70] Part 1 of Schedule 1, omit item dealing with Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
[71] Part 1 of Schedule 1, after item dealing with Sotalol
insert in the columns in the order indicated:
| Soy protein and fat formula with vitamins and minerals — carbohydrate free | Oral liquid 384 mL (RCF) | Oral | 120 | 5 | RCF |
[72] Part 1 of Schedule 1, after item dealing with Trifluoperazine
insert in the columns in the order indicated:
| Triglycerides, medium chain | Oil 500 mL (MCT Oil) | Oral | 2 | 5 | MCT Oil |
| Triglycerides, medium chain and long chain with glucose polymer | Oral powder 400 g (Duocal) | Oral | 8 | 5 | Duocal |
| Triglycerides — medium chain, formula | Oral powder 400 g (Monogen) | Oral | 8 | 5 | Monogen |
| Oral powder 420 g (Caprilon) | Oral | 8 | 5 | Caprilon |
[73] Part 1 of Schedule 1, omit item dealing with Triglycerides Oil – Medium Chain
[74] Part 1 of Schedule 1, omit item dealing with “TYR Express”
[75] Part 1 of Schedule 1, omit item dealing with “TYR gel”
[76] Part 1 of Schedule 1, after item dealing with Warfarin
insert in the columns in the order indicated:
| Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | Oral powder 400 g (Kindergen) | Oral | 16 | 5 | Kindergen |
[77] Part 1 of Schedule 1, omit item dealing with “XLYS, LOW TRY Analog”
[78] Part 1 of Schedule 1, omit item dealing with “XLYS, LOW TRY Maxamaid”
[79] Part 1 of Schedule 1, omit item dealing with “XMET Analog”
[80] Part 1 of Schedule 1, omit item dealing with “XMET Maxamaid”
[81] Part 1 of Schedule 1, omit item dealing with “XMET Maxamum”
[82] Part 1 of Schedule 1, omit item dealing with “XMTVI Analog”
[83] Part 1 of Schedule 1, omit item dealing with “XMTVI Asadon”
[84] Part 1 of Schedule 1, omit item dealing with “XMTVI Maxamaid”
[85] Part 1 of Schedule 1, omit item dealing with “XMTVI Maxamum”
[86] Part 1 of Schedule 1, omit item dealing with “XP Analog”
[87] Part 1 of Schedule 1, omit item dealing with “XP Analog LCP”
[88] Part 1 of Schedule 1, omit item dealing with “XPhen, Tyr Analog”
[89] Part 1 of Schedule 1, omit item dealing with “XPhen, Tyr Maxamaid”
[90] Part 1 of Schedule 1, omit item dealing with “XPhen, Tyr Maxamum”
[91] Part 1 of Schedule 1, omit item dealing with “XP Maxamaid”
[92] Part 1 of Schedule 1, omit item dealing with “XP Maxamum”
[93] Part 1 of Schedule 1, omit item dealing with “XPTM Tyrosidon”
[94] Part 2 of Schedule 1, after item dealing with Albendazole
| Amino acids — synthetic, formula | Oral powder 400 g (EleCare) | In compliance with authority procedures set out in subparagraph 11 (d) : Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Oral | 8 | 5 | EleCare |
| Oral powder 400 g (Neocate) | In compliance with authority procedures set out in subparagraph 11 (d) : Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Oral | 8 | 5 | Neocate | |
| Oral powder 400 g (Neocate Advance) | In compliance with authority procedures set out in subparagraph 11 (d) : Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Oral | 8 | 5 | Neocate Advance | |
| Oral powder 400 g (Neocate Advance Tropical Flavour) | In compliance with authority procedures set out in subparagraph 11 (d) : Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Oral | 8 | 5 | Neocate Advance Tropical Flavour | |
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) | In compliance with authority procedures set out in subparagraph 11 (d) : Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Oral | 8 | 5 | Neocate LCP |
[95] Part 2 of Schedule 1, omit item dealing with “Digestelact”
[96] Part 2 of Schedule 1, omit item dealing with “EleCare”
[97] Part 2 of Schedule 1, omit item dealing with “Karicare De-Lact”
[98] Part 2 of Schedule 1, after item dealing with Metronidazole
insert in the columns in the order indicated:
| Milk powder — lactose free formula | Oral powder 900 g (S-26 LF) | In compliance with authority procedures set out in subparagraph 11 (d) : Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | Oral | 5 | 5 | S-26 LF |
| Oral powder 900 g (Karicare De-Lact) | In compliance with authority procedures set out in subparagraph 11 (d) : Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | Oral | 5 | 5 | Karicare De-Lact | |
| Milk powder — lactose modified | Oral powder 900 g (Digestelact) | In compliance with authority procedures set out in subparagraph 11 (d) : Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | Oral | 3 | 10 | Digestelact |
[99] Part 2 of Schedule 1, omit item dealing with “Neocate”
[100] Part 2 of Schedule 1, omit item dealing with “Neocate Advance”
[101] Part 2 of Schedule 1, omit item dealing with “Neocate Advance Tropical Flavour”
[102] Part 2 of Schedule 1, omit item dealing with “Neocate LCP”
[103] Part 2 of Schedule 1, omit item dealing with “S-26 LF”
[104] Part 1 of Schedule 3, item dealing with Prochlorperazine
omit from the column headed “Form (strength, type, size, etc.)”:
| Suppositories, 3 mg, equivalent to 5 mg prochlorperazine maleate, 5 |
| Suppositories, 15 mg, equivalent to 25 mg prochlorperazine maleate, 5 |
and substitute:
| Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 |
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 |
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