✨ Medicines Consent Notices




7 OCTOBER 2010 NEW ZEALAND GAZETTE, No. 138 3479

Medicines Act 1981

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: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Watson Laboratories Inc, New York, United States of America
Watson Pharma Private Limited, Goa, India

Product: AFT-Leflunomide
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada

Product: AFT-Leflunomide
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada

Product: Carboplatin
Active Ingredient: Carboplatin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Dimetapp PE Nasal Decongestant
Active Ingredient: Phenylephrine hydrochloride 10mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Australia

Product: Fluoxetine - AFT
Active Ingredient: Fluoxetine hydrochloride 4mg/mL equivalent to fluoxetine 20mg per 5mL
Dosage Form: Oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Clonmel, Ireland

Product: Obecalpton
Active Ingredients: Codeine phosphate hemihydrate 8mg equivalent to 5.92mg codeine
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India

Product: Ovestin Ovula
Active Ingredient: Oestriol 0.5mg
Dosage Form: Pessary
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Unither Industries, Gannat, France

Product: Panadol Sinus PE Night & Day
Day tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet

Night tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 138





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Consent, Distribution, New Zealand, Pharmaceuticals
  • Minister of Health