✨ Medicines Approval Notices




17 JANUARY 2013

NEW ZEALAND GAZETTE, No. 2


Health


Medicines Act 1981

Consent to the Distribution of New Medicines

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



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 2





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Approval, Lamivudine, SmofKabiven, Distribution
  • Minister of Health