✨ Consent to Distribution of New Medicines




3 JUNE 2010

NEW ZEALAND GAZETTE, No. 61

1775

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: Apo - Leflunomide

  • Active Ingredient: Leflunomide 20mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Apotex NZ Limited
  • Manufacturer: Apotex Inc, Weston, Canada

Product: Apo - Leflunomide

  • Active Ingredient: Leflunomide 10mg
  • Dosage Form: Tablet
  • New Zealand Sponsor: Apotex NZ Limited
  • Manufacturer: Apotex Inc, Weston, Canada

Product: Cefepime Injection 500mg

  • Active Ingredients: Cefepime dihydrochloride monohydrate 575.9mg equivalent to 500mg cefepime free base
  • Dosage Form: Powder for injection
  • New Zealand Sponsor: Mylan New Zealand Limited
  • Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India

Product: Cefepime Injection 1g

  • Active Ingredient: Cefepime dihydrochloride monohydrate 1.1518g equivalent to 1g cefepime free base
  • Dosage Form: Powder for injection
  • New Zealand Sponsor: Mylan New Zealand Limited
  • Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India

Product: Cefepime Injection 2g

  • Active Ingredient: Cefepime dihydrochloride monohydrate 2.3036g equivalent to 2g cefepime free base
  • Dosage Form: Powder for injection
  • New Zealand Sponsor: Mylan New Zealand Limited
  • Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India

Product: Codral Relief Cold & Flu

  • Active Ingredients: Paracetamol 500mg
    Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
  • Dosage Form: Tablet
  • New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
  • Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa

Product: Colgate Sensitive Enamel Protect Plus Whitening

  • Active Ingredients: Potassium citrate monohydrate 5.53%w/w
    Sodium monofluorophosphate 0.76%w/w
  • Dosage Form: Toothpaste
  • New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
  • Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Thailand

Product: Difflam Anaesthetic, Antibacterial & Anti-inflammatory Sugar Free Berry

  • Active Ingredients: Benzydamine hydrochloride 3mg
    Dichlorobenzyl alcohol 1.2mg
    Lidocaine hydrochloride, anhydrous 4mg
  • Dosage Form: Lozenge
  • New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
  • Manufacturer: Nestle Australia Limited, Blacktown, Australia

Product: Difflam Anaesthetic, Antibacterial & Anti-inflammatory Sugar Free Menthol & Eucalyptus

  • Active Ingredients: Benzydamine hydrochloride 3mg
    Dichlorobenzyl alcohol 1.2mg
    Lidocaine hydrochloride, anhydrous 4mg
  • Dosage Form: Lozenge
  • New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
  • Manufacturer: Nestle Australia Limited, Blacktown, Australia


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 61





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
26 May 2010
Medicines Act, New Medicines, Distribution Consent, Leflunomide, Cefepime, Codral, Colgate, Diffam
  • Minister of Health