✨ Medicines Consent Notices




9 OCTOBER 2014 NEW ZEALAND GAZETTE, No. 122 3453

Product: Dobutamine-Claris
Active Ingredient: Dobutamine hydrochloride 14.01mg/mL equivalent to Dobutamine 12.5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India

Product: Hydralyte Colour Free Lemonade Flavoured Electrolyte Ice Blocks
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.2mg/mL
Sodium chloride 2.5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: The Hydration Pharmaceutical Trust, Sydney, Australia

Product: Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.213mg/mL
Sodium chloride 2.528mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: The Hydration Pharmaceutical Trust, Sydney, Australia

Product: Prezista
Active Ingredient: Darunavir ethanolate 867.28mg equivalent to Darunavir 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Vitekta
Active Ingredient: Elvitegravir 85mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada

Product: Vitekta
Active Ingredient: Elvitegravir 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada

Dated this 3rd day of October 2014.

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

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Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Dexamfetamine Tablets
Active Ingredient: Dexamfetamine sulfate 5mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 122





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
3 October 2014
Medicines Act 1981, New Medicines, Consent to Distribution, Dobutamine-Claris, Hydralyte, Prezista, Vitekta
  • Stewart Jessamine, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicine, Consent to Distribution, Dexamfetamine Tablets