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: Apo-Alendronate
Active Ingredient: Alendronate sodium trihydrate 91.35mg equivalent to 70mg alendronate
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Megestrol
Active Ingredient: Megestrol acetate 160mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Megestrol
Active Ingredient: Megestrol acetate 40mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: m-Aciclovir
Active Ingredient: Aciclovir 250mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Reig Jofre SA, Sant Joan Despi, Barcelona, Spain
Product: Nausicalm
Active Ingredient: Cyclizine lactate 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Cenexi SAS, Fontenay-sous-Bois, France
Product: Oliclinomel N4-550
Active Ingredients: Alanine 11.39g/L
Arginine 6.33g/L
Glycine 5.67g/L
Histidine 2.64g/L
Isoleucine 3.3g/L
Leucine 4.02g/L
Lysine hydrochloride 3.99g/L equivalent to lysine 3.19g/L
Methionine 2.2g/L
Phenylalanine 3.08g/L
Proline 3.74g/L
Serine 2.75g/L
Threonine 2.31g/L
Tryptophan 0.99g/L
Tyrosine 0.22g/L
Valine 3.19g/L
Glucose monohydrate 220g/L equivalent to glucose 200g/L
Olive oil 80g/L
Soya oil 20g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N4-550E
Active Ingredients: Alanine 11.39g/L
Arginine 6.33g/L
Glycine 5.67g/L
Histidine 2.64g/L
Isoleucine 3.3g/L
Leucine 4.02g/L
Lysine hydrochloride 3.99g/L equivalent to lysine 3.19g/L
Magnesium chloride hexahydrate 1.12g/L
Methionine 2.2g/L
Phenylalanine 3.08g/L
Potassium chloride 2.98g/L
Proline 3.74g/L
Serine 2.75g/L
Sodium acetate trihydrate 2.45g/L
Sodium glycerophosphate pentahydrate 5.36g/L
Threonine 2.31g/L
Tryptophan 0.99g/L
Tyrosine 0.22g/L
Valine 3.19g/L
Calcium chloride dihydrate 0.74g/L
Glucose monohydrate 220g/L equivalent to glucose 200g/L
Olive oil 80g/L
Soya oil 20g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N5-800
Active Ingredients: Alanine 14.49g/L
Arginine 8.05g/L
Glycine 7.21g/L
Histidine 3.36g/L
Isoleucine 4.2g/L
Leucine 5.11g/L
Lysine hydrochloride 5.07g/L equivalent to lysine 4.06g/L
Methionine 2.8g/L
Phenylalanine 3.92g/L
Proline 4.76g/L
Serine 3.5g/L
Threonine 2.94g/L
Tryptophan 1.26g/L
Tyrosine 0.28g/L
Valine 4.06g/L
Glucose monohydrate 275g/L equivalent to glucose 250g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N5-800E
Active Ingredients: Alanine 14.49g/L
Arginine 8.05g/L
Glycine 7.21g/L
Histidine 3.36g/L
Isoleucine 4.2g/L
Leucine 5.11g/L
Lysine hydrochloride 5.07g/L equivalent to lysine 4.06g/L
Magnesium chloride hexahydrate 1.12g/L
Methionine 2.8g/L
Phenylalanine 3.92g/L
Potassium chloride 4.47g/L
Proline 4.76g/L
Serine 3.5g/L
Sodium acetate trihydrate 6.12g/L
Sodium glycerophosphate pentahydrate 5.36g/L
Threonine 2.94g/L
Tryptophan 1.26g/L
Tyrosine 0.28g/L
Valine 4.06g/L
Calcium chloride dihydrate 0.74g/L
Glucose monohydrate 275g/L equivalent to glucose 250g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N6-900
Active Ingredients: Alanine 17.6g/L
Arginine 9.78g/L
Glycine 8.76g/L
Histidine 4.08g/L
Isoleucine 5.1g/L
Leucine 6.21g/L
Lysine hydrochloride 6.16g/L equivalent to lysine 4.93g/L
Methionine 3.4g/L
Phenylalanine 4.76g/L
Proline 5.78g/L
Serine 4.25g/L
Threonine 3.57g/L
Tryptophan 1.53g/L
Tyrosine 0.34g/L
Valine 4.93g/L
Glucose monohydrate 330g/L equivalent to glucose 300g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N6-900E
Active Ingredients: Alanine 17.6g/L
Arginine 9.78g/L
Glycine 8.76g/L
Histidine 4.08g/L
Isoleucine 5.1g/L
Leucine 6.21g/L
Lysine hydrochloride 6.16g/L equivalent to lysine 4.93g/L
Magnesium chloride hexahydrate 1.12g/L
Methionine 3.4g/L
Phenylalanine 4.76g/L
Potassium chloride 4.47g/L
Proline 5.78g/L
Serine 4.25g/L
Sodium acetate trihydrate 6.12g/L
Sodium glycerophosphate pentahydrate 5.36g/L
Threonine 3.57g/L
Tryptophan 1.53g/L
Tyrosine 0.34g/L
Valine 4.93g/L
Calcium chloride dihydrate 0.74g/L
Glucose monohydrate 330g/L equivalent to glucose 300g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N7-1000
Active Ingredients: Alanine 20.7g/L
Arginine 11.5g/L
Glycine 10.3g/L
Histidine 4.8g/L
Isoleucine 6g/L
Leucine 7.3g/L
Lysine hydrochloride 7.25g/L equivalent to lysine 5.8g/L
Methionine 4g/L
Phenylalanine 5.6g/L
Proline 6.8g/L
Serine 5g/L
Threonine 4.2g/L
Tryptophan 1.8g/L
Tyrosine 0.4g/L
Valine 5.8g/L
Glucose monohydrate 440g/L equivalent to glucose 400g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Oliclinomel N7-1000E
Active Ingredients: Alanine 20.7g/L
Arginine 11.5g/L
Glycine 10.3g/L
Histidine 4.8g/L
Isoleucine 6g/L
Leucine 7.3g/L
Lysine hydrochloride 7.25g/L equivalent to lysine 5.8g/L
Magnesium chloride hexahydrate 1.12g/L
Methionine 4g/L
Phenylalanine 5.6g/L
Potassium chloride 4.47g/L
Proline 6.8g/L
Serine 5g/L
Sodium acetate trihydrate 6.12g/L
Sodium glycerophosphate pentahydrate 5.36g/L
Threonine 4.2g/L
Tryptophan 1.8g/L
Tyrosine 0.4g/L
Valine 5.8g/L
Calcium chloride dihydrate 0.74g/L
Glucose monohydrate 440g/L equivalent to glucose 400g/L
Olive oil 160g/L
Soya oil 40g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter SA, Lessines, Belgium
Clintec Parenteral S.A., Montargis, France
Product: Panadol Back & Neck
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Co. Waterford, Ireland
Product: Pediacel
Active Ingredients: Diphtheria toxoid, adsorbed 15Lf U
Haemophilus influenzae type b polysaccharide 10µg
Pertactin 3µg
Pertussis filamentous haemagglutinin 20µg
Pertussis fimbriae 2+3 5µg
Pertussis toxoid, adsorbed 20µg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20µg
Tetanus toxoid, adsorbed 5Lf U
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Toronto, Ontario, Canada
Product: Poliacel (Combination Product)
Active Ingredients: Diphtheria toxoid, adsorbed 15Lf U
Pertactin 3µg
Pertussis filamentous haemagglutinin 20µg
Pertussis fimbriae 2+3 5µg
Pertussis toxoid, adsorbed 20µg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 5Lf U
Haemophilus influenzae type b polysaccharide 10µg
Dosage Form: Powder for suspension
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
New Zealand Sponsor: sanofi-aventis new zealand limited
Product: Vicks Cough Syrup with Honey for Dry Cough
Active Ingredient: Dextromethorphan hydrobromide monohydrate 1.333mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Procter & Gamble Distributing New Zealand
Manufacturer: Procter & Gamble GmbH, Gross Gerau, Germany
Product: Zantac Liquid
Active Ingredient: Ranitidine hydrochloride 16.8g/mL equivalent to Ranitidine 15mg/mL
Dosage Form: Syrup
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome GmbH & Co, Bad Oldesloe, Germany
Dated this 16th day of July 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).