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: Lamivudine
Active Ingredient: Lamivudine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: SmofKabiven
Amino acid component:
Active Ingredients: Alanine 14g/L
Arginine 12g/L
Calcium chloride dihydrate 0.74g/L
Glycine 11g/L
Histidine 3g/L
Isoleucine 5g/L
Leucine 7.4g/L
Lysine acetate 9.3g/L equivalent to L-Lysine 6.6g/L
Magnesium sulfate heptahydrate 2.47g/L equivalent to magnesium sulphate 1.2g
Methionine 4.3g/L
Phenylalanine 5.1g/L
Potassium chloride 4.48g/L
Proline 11.2g/L
Serine 6.5g/L
Sodium acetate trihydrate 5.62g/L equivalent to sodium acetate 3.4g
Sodium glycerophosphate 4.18g/L
Taurine 1g/L
Threonine 4.4g/L
Tryptophan 2g/L
Tyrosine 0.4g/L
Valine 6.2g/L
Zinc sulfate heptahydrate 0.023g/L equivalent to zinc sulphate 0.0129g
Dosage Form: Solution for infusion
Glucose component:
Active Ingredient: Glucose monohydrate 462g/L equivalent to glucose (anhydrous) 420g/L
Dosage Form: Solution for infusion
Lipid component:
Active Ingredients: Fish oil 30g/L
Medium-chain triglycerides 60g/L
Olive oil 50g/L
Soya oil 60g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Product: SmofKabiven Electrolyte Free
Amino acid component:
Active Ingredients: Alanine 14g/L
Arginine 12g/L
Glycine 11g/L
Histidine 3g/L
Isoleucine 5g/L
Leucine 7.4g/L
Lysine acetate 9.3g/L equivalent to L-Lysine 6.6g
Methionine 4.3g/L
Phenylalanine 5.1g/L
Proline 11.2g/L
Serine 6.5g/L
Taurine 1g/L
Threonine 4.4g/L
Tryptophan 2g/L
Tyrosine 0.4g/L
Valine 6.2g/L
Dosage Form: Solution for infusion
Glucose component:
Active Ingredient: Glucose monohydrate 462g/L equivalent to glucose (anhydrous) 420g/L
Dosage Form: Solution for infusion
Lipid component:
Active Ingredients: Fish oil 30g/L
Medium-chain triglycerides 60g/L
Olive oil 50g/L
Soya oil 60g/L
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Product: Systane Balance Lubricant Eye Drops
Active Ingredient: Propylene glycol 0.6%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Cusi SA, Barcelona, Spain
Product: Your Pharmacy Cetirizine Tablets
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Company, Michigan, United States of America
Dated this 9th day of January 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).