Consent to Distribution of New Medicines




15 JULY 2010

NEW ZEALAND GAZETTE, No. 83

2275

Dated this 8th day of July 2010.

JANICE WILSON, 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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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: Abraxane
Active Ingredient: Paclitaxel 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Specialised Therapeutics Limited
Manufacturers:

  • APP Pharmaceuticals LLC, Illinois, United States of America
  • APP Pharmaceuticals LLC, New York, United States of America
  • Abraxis BioScience LLC, Illinois, United States of America
  • Abraxis BioScience LLC, New York, United States of America

Product: Confirm
Active Ingredients:

  • Goat anti-alpha-hCG polyclonal antibody 0.05μg
  • Goat anti-mouse polyclonal antibody 0.05μg
  • Murine monoclonal antibody to beta HCG 0.05μg
    Dosage Form: Pregnancy test kit
    New Zealand Sponsor: Ebos Group Limited
    Manufacturer: Germaine Laboratories Inc., San Antonio, United States of America

Product: Diamide Relief (Pharmacy Only)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India

Product: Diamide Relief (Prescription)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India

Product: Ibucode Plus
Active Ingredients:

  • Codeine phosphate, hemihydrate 12.8mg
  • Ibuprofen 200mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
    Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bommasandra, India

Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 10mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 20mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Product: Isopto Carpine
Active Ingredient: Pilocarpine hydrochloride 40mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium

Product: Paracetamol 120mg/5 mL
Active Ingredient: Paracetamol 2.4%w/v
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Mediorals Laboratories Pvt Limited, Satara, India



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Gazette.govt.nz PDF NZ Gazette 2010, No 83





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine (continued from previous page)

🏥 Health & Social Welfare
8 July 2010
Medicines Act 1981, New Medicine, Abraxane, Confirm, Diamide Relief, Ibucode Plus, Isopto Carpine, Paracetamol
  • Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health