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:*	Gaviscon Double Strength
Active Ingredients:	Calcium carbonate 20mg/mL Potassium bicarbonate 20mg/mL Sodium alginate 100mg/mL
Dosage Form:	Oral suspension
New Zealand Sponsor:	Reckitt Benckiser (New Zealand) Limited
Manufacturer:	Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom

*Product:*	SmofKabiven NTense
*Amino acid component:* Active Ingredients:	Alanine 14g/L Arginine 12g/L Calcium chloride dihydrate 0.574g/L equivalent to calcium chloride 0.434g/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 1.92g/L equivalent to magnesium sulfate 0.931g/L Methionine 4.3g/L Phenylalanine 5.1g/L Potassium chloride 3.48g/L Proline 11.2g/L Serine 6.5g/L Sodium acetate trihydrate 4.1g/L equivalent to sodium acetate 2.47g/L Sodium glycerophosphate 3.48g/L Taurine 1g/L Threonine 4.4g/L Tryptophan 2g/L Tyrosine 0.4g/L Valine 6.2g/L Zinc sulfate heptahydrate 0.0178g/L equivalent to zinc sulfate 0.0100g/L
Dosage Form:	Solution for infusion
*Glucose component:* Active Ingredient:	Glucose monohydrate 462g/L equivalent to glucose 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

Dated this 22nd day of June 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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