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:*	Elevit
Active Ingredients:	Ascorbic acid 93.5mg Biotin 35mcg Calcium hydrogen phosphate 422.37mg Calcium pantothenate 7.17mg Colecalciferol 13.5mg Copper sulfate 2.51mg Cyanocobalamin 3.38mcg DL-alpha Tocopheryl acetate 59.45mg Ferrous bisglycinate 117.39mg Folic acid 480mcg Heavy magnesium oxide 165.8mg Levomefolate calcium 541mcg Manganese sulfate monohydrate 6.15mg Nicotinamide 18.9mg Potassium iodide 288mcg Pyridoxine hydrochloride 2.54mg Riboflavin 1.54mg Sodium selenite 110mcg Thiamine nitrate 2.16mg Zinc citrate trihydrate 35.23mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Bayer New Zealand Limited
Manufacturer:	PT Bayer Indonesia, Kota Depok, Indonesia

*Product:*	Noumed Paracetamol Osteo
Active Ingredient:	Paracetamol 665mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Noumed Pharmaceuticals Limited
Manufacturer:	Adcock Ingram Limited – A Medreich Group Company, Bangalore, India

*Product:*	Ontruzant
Active Ingredient:	Trastuzumab 150mg
Dosage Form:	Powder for injection
New Zealand Sponsor:	Samsung Bioepis NZ Limited
Manufacturers:	Patheon Italia S.p.A, Ferentino, Italy Fareva Pau SAS, Idron, France

*Product:*	Paracetamol Osteo
Active Ingredient:	Paracetamol 665mg
Dosage Form:	Modified release tablet
New Zealand Sponsor:	Noumed Pharmaceuticals Limited
Manufacturer:	Adcock Ingram Limited – A Medreich Group Company, Bangalore, India

*Product:*	Vazkepa
Active Ingredient:	Icosapent ethyl 998mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	AA-Med NZ Limited
Manufacturers:	Capsugel, Ploermel, France Patheon Softgels B.V., Tilburg, Netherlands Patheon Softgels, Inc., North Carolina, United States of America

Dated this 20th day of January 2023.

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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