✨ Medicines Consent and Classification




11 NOVEMBER 2010 NEW ZEALAND GAZETTE, No. 150 3781

Schedule

Product: Duphalac Fruity
Active Ingredient: Lactulose 667mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Abbott Biologicals BV, Olst, The Netherlands

Product: Oxaliplatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Systane Lubricant Eye Drops
Active Ingredients: Macrogol 400 0.4%w/v
Propylene glycol 0.3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Laboratories Alcon S.A., Kaysersberg, France

Product: Systane Ultra Lubricating Eye Drops
Active Ingredients: Macrogol 400 0.4%w/v
Propylene glycol 0.3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Cusi SA, Barcelona, Spain

Dated this 3rd day of November 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Levothyroxine
Active Ingredient: Levothyroxine sodium, anhydrous 0.1mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir New Zealand Limited t/a Goldshield Healthcare (New Zealand)
Manufacturer: Custom Pharmaceuticals Limited (UK), Sussex, United Kingdom
Note: This renewed consent is valid for two years from 11 November 2010.

Product: Levothyroxine
Active Ingredient: Levothyroxine sodium, anhydrous 0.05mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir New Zealand Limited t/a Goldshield Healthcare (New Zealand)
Manufacturer: Custom Pharmaceuticals Limited (UK), Sussex, United Kingdom
Note: This renewed consent is valid for two years from 11 November 2010.

Dated this 3rd day of November 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Stewart Jessamine, Acting Deputy Director-General, Population Health Directorate, Ministry of Health, acting under delegated authority, hereby declare the following:

  1. The medicine listed in Schedule 1 to this notice is classified as a prescription medicine.
  2. The medicine listed in Schedule 2 to this notice is classified as a restricted medicine.
  3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(c) preparations or extracts of biological materials listed in the notice.

(d) salts or oxides of elements listed in the notice.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 150





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
3 November 2010
Medicines, Consent, Distribution, Health
  • STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
3 November 2010
Medicines, Renewal, Consent, Health
  • STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health

πŸ₯ Classification of Medicines

πŸ₯ Health & Social Welfare
3 November 2010
Medicines, Classification, Health
  • STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health