✨ Medicines Consent




13 JANUARY 2011

NEW ZEALAND GAZETTE, No. 1

33

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: A-Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India

Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 539.65mg equivalent to ceftriaxone 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonim Sirketi, Kirklareli, Turkey

Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 1.0793g equivalent to ceftriaxone 1g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonim Sirketi, Kirklareli, Turkey

Product: Ceftriaxone-AFT
Active Ingredient: Ceftriaxone sodium 2.1586g equivalent to ceftriaxone 2g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Eczabasi-Zentiva Saglik Urunleri Sanayi ve Ticaret Anonim Sirketi, Kirklareli, Turkey

Product: Hemosol B0
Electrolyte Solution
Active Ingredients:

  • Calcium chloride dihydrate 5.145g
  • Lactic acid 5.4g equivalent to lactic acid solution 90% w/w 6g
  • Magnesium chloride hexahydrate 2.033g
    Dosage Form: Dialysis solution

Buffer Solution
Active Ingredients:

  • Sodium bicarbonate 3.09g
  • Sodium chloride 6.45g
    Dosage Form: Dialysis solution
    New Zealand Sponsor: Gambro Pty Limited (NZ)
    Manufacturer: Gambro Dasco SpA, Sondalo, Italy

Product: Humira
Active Ingredient: Adalimumab 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: I-Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India

Product: Loperamide capsules
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India

Product: Maxiclear Cold & Nasal Relief
Active Ingredients:

  • Loratadine 2.5mg
  • Phenylephrine hydrochloride 10mg equivalent to phenylephrine 8.2mg
    Dosage Form: Tablet
    New Zealand Sponsor: AFT Pharmaceuticals Limited
    Manufacturer: Sigma Laboratories Limited, Goa, India


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 1





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
13 January 2011
Medicines Act 1981, Consent, New Medicines, Distribution
  • Minister of Health