Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Adenuric
Active Ingredient: Febuxostat 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Patheon France SA, Bourgoin-Jallieu, France
Product: Adenuric
Active Ingredient: Febuxostat 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Patheon France SA, Bourgoin-Jallieu, France
Product: Apo-Valgan
Active Ingredient: Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Pharmachem India Pvt. Limited, Bangalore, India
Product: Docetaxel Sandoz (20mg/2mL)
Active Ingredient: Docetaxel 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany
Product: Docetaxel Sandoz (80mg/8mL)
Active Ingredient: Docetaxel 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany
Product: Olimel N5-860E
Amino Acid solution compartment:
Active Ingredients: Alanine 11.9g/L
Arginine 8.06g/L
Aspartic acid 2.38g/L
Glutamic acid 4.11g/L
Glycine 5.7g/L
Histidine 4.91g/L
Isoleucine 4.11g/L
Leucine 5.7g/L
Lysine acetate 9.13g/L equivalent to lysine 6.47g/L
Magnesium chloride hexahydrate 2.03g/L
Methionine 4.11g/L
Phenylalanine 5.7g/L
Potassium chloride 5.59g/L
Proline 4.91g/L
Serine 3.25g/L
Sodium acetate trihydrate 3.74g/L
Sodium glycerophosphate 9.18g/L
Threonine 4.11g/L
Tryptophan 1.37g/L
Tyrosine 0.21g/L
Valine 5.26g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredients: Calcium chloride dihydrate 1.29g/L
Glucose monohydrate 316.25g/L equivalent to glucose 287.5g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Olimel N7-960
Amino Acid solution compartment:
Active Ingredients: Alanine 16.02g/L
Arginine 10.85g/L
Aspartic acid 3.2g/L
Glutamic acid 5.53g/L
Glycine 7.67g/L
Histidine 6.61g/L
Isoleucine 5.53g/L
Leucine 7.67g/L
Lysine acetate 12.19g/L equivalent to lysine 8.71g/L
Methionine 5.53g/L
Phenylalanine 7.67g/L
Proline 6.61g/L
Serine 4.37g/L
Threonine 5.53g/L
Tryptophan 1.84g/L
Tyrosine 0.28g/L
Valine 7.08g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredient: Glucose monohydrate 385g/L equivalent to glucose 350g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Olimel N7-960E
Amino Acid solution compartment:
Active Ingredients: Alanine 16.02g/L
Arginine 10.85g/L
Aspartic acid 3.2g/L
Glutamic acid 5.53g/L
Glycine 7.67g/L
Histidine 6.61g/L
Isoleucine 5.53g/L
Leucine 7.67g/L
Lysine acetate 12.19g/L equivalent to lysine 8.71g/L
Magnesium chloride hexahydrate 2.03g/L
Methionine 5.53g/L
Phenylalanine 7.67g/L
Potassium chloride 5.59g/L
Proline 6.61g/L
Serine 4.37g/L
Sodium acetate trihydrate 3.74g/L
Sodium glycerophosphate 9.18g/L
Threonine 5.53g/L
Tryptophan 1.84g/L
Tyrosine 0.28g/L
Valine 7.08g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredients: Calcium chloride dihydrate 1.29g/L
Glucose monohydrate 385g/L equivalent to glucose 350g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Olimel N9-840
Amino Acid solution compartment:
Active Ingredients: Alanine 20.6g/L
Arginine 13.95g/L
Aspartic acid 4.12g/L
Glutamic acid 7.11g/L
Glycine 9.87g/L
Histidine 8.49g/L
Isoleucine 7.11g/L
Leucine 9.87g/L
Lysine acetate 15.8g/L equivalent to lysine 11.2g/L
Methionine 7.11g/L
Phenylalanine 9.87g/L
Proline 8.49g/L
Serine 5.62g/L
Threonine 7.11g/L
Tryptophan 2.37g/L
Tyrosine 0.37g/L
Valine 9.11g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredients: Calcium chloride dihydrate 1.29g/L
Glucose monohydrate 302.5g/L equivalent to glucose 275g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Olimel N9-840E
Amino Acid solution compartment:
Active Ingredients: Alanine 20.6g/L
Arginine 13.95g/L
Aspartic acid 4.12g/L
Glutamic acid 7.11g/L
Glycine 9.87g/L
Histidine 8.49g/L
Isoleucine 7.11g/L
Leucine 9.87g/L
Lysine acetate 15.8g/L equivalent to lysine 11.2g/L
Magnesium chloride hexahydrate 2.03g/L
Methionine 7.11g/L
Phenylalanine 9.87g/L
Potassium chloride 5.59g/L
Proline 8.49g/L
Serine 5.62g/L
Sodium acetate trihydrate 3.74g/L
Sodium glycerophosphate 9.18g/L
Threonine 7.11g/L
Tryptophan 2.37g/L
Tyrosine 0.37g/L
Valine 9.11g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredients: Calcium chloride dihydrate 1.29g/L
Glucose monohydrate 302.5g/L equivalent to glucose 275g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Oxydone BNM
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Oxydone BNM
Active Ingredient: Oxycodone hydrochloride 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Oxydone BNM
Active Ingredient: Oxycodone hydrochloride 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Oxydone BNM
Active Ingredient: Oxycodone hydrochloride 80mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: PeriOlimel N4-600E
Amino Acids solution compartment:
Active Ingredients: Alanine 9.16g/L
Arginine 6.2g/L
Aspartic acid 1.83g/L
Glutamic acid 3.16g/L
Glycine 4.39g/L
Histidine 3.77g/L
Isoleucine 3.16g/L
Leucine 4.39g/L
Lysine acetate 7.02g/L equivalent to lysine 4.98g/L
Magnesium chloride hexahydrate 1.12g/L
Methionine 3.16g/L
Phenylalanine 4.39g/L
Potassium chloride 2.98g/L
Proline 3.77g/L
Serine 2.5g/L
Sodium acetate trihydrate 2.89g/L
Sodium glycerophosphate 4.78g/L
Threonine 3.16g/L
Tryptophan 1.06g/L
Tyrosine 0.16g/L
Valine 4.05g/L
Dosage Form: Solution for infusion
Glucose solution compartment:
Active Ingredients: Calcium chloride dihydrate 0.74g/L
Glucose monohydrate 206.25g/L equivalent to glucose 187.5g/L
Dosage Form: Solution for infusion
Lipid emulsion compartment:
Active Ingredients: Olive oil 120g/L
Soya oil 30g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter SA, Lessines, Belgium
Product: Prolox
Active Ingredient: Rabeprazole sodium 10mg equivalent to rabeprazole 9.42mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: Prolox
Active Ingredient: Rabeprazole sodium 20mg equivalent to rabeprazole 18.85mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Dated this 21st day of February 2013.
DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).