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: 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).