Consent to the Distribution of New Medicines

A corrigendum to this notice was published on 7 July 2021, Notice No. 2021-go2761.

Notice Type: Departmental
Notice Title: 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:*	Bendamustine-Teva
Active Ingredient:	Bendamustine hydrochloride 25mg
Dosage Form:	Powder for infusion concentrate
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	SC Sindan-Pharma SrL, Bucharest, Romania

*Product:*	Bendamustine-Teva
Active Ingredient:	Bendamustine hydrochloride 100mg
Dosage Form:	Powder for infusion concentrate
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	SC Sindan-Pharma SrL, Bucharest, Romania

*Product:*	Dexmedetomidine Accord
Active Ingredient:	Dexmedetomidine hydrochloride 118mcg/mL equivalent to dexmedetomidine 100mcg/mL
Dosage Form:	Concentrate for injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Intas Pharmaceuticals Limited, Sanand, India

*Product:*	Hyoscine Butylbromide (Medicianz)
Active Ingredient:	Hyoscine butylbromide 20mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Hyoscine Butylbromide (Medsurge)
Active Ingredient:	Hyoscine butylbromide 20mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Medicianz Healthcare Limited
Manufacturer:	HBM Pharma s.r.o., Martin, Slovakia

*Product:*	Ibuprofen (General sale)
Active Ingredient:	Ibuprofen 200mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	PSM Healthcare Limited trading as API Consumer Brands
Manufacturer:	Medreich Limited, Bangalore, India

*Product:*	Ibuprofen (Pharmacy only)
Active Ingredient:	Ibuprofen 200mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	PSM Healthcare Limited trading as API Consumer Brands
Manufacturer:	Medreich Limited, Bangalore, India

*Product:*	SmofKabiven Low Osmo
Amino acid component:
Active Ingredients:	Alanine 14g/L Arginine 12g/L Calcium chloride dihydrate 0.74g/L equivalent to calcium chloride 0.56g/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 sulfate 1.2g/L 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/L Sodium glycerophosphate 4.18mg/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 sulfate 0.0129g/L
Dosage Form:	Solution for infusion
*Glucose component:*
Active Ingredient:	Glucose monohydrate 130g/L equivalent to glucose 118g/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 16th day of April 2021.

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

Publication Date: 22 Apr 2021

Tags: Medicines Act Consent to the distribution of new medicines Health

Notice Number: 2021-go1438

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