✨ Medicines Act Consents




8 JANUARY 2009 NEW ZEALAND GAZETTE, No. 1

53

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: Apomine PFS

Active Ingredient: Apomorphine hydrochloride hemihydrate 5mg/mL

Dosage Form: Solution for infusion

New Zealand Sponsor: Hospira NZ Limited

Manufacturer: S C Federa, Belgium

Product: Codral Cold & Flu + Cough Day & Night (Combination Pack)

Night Capsule

Active Ingredients:

  • Chlorphenamine maleate 2mg
  • Dextromethorphan hydrobromide monohydrate 10mg equivalent to 7.3mg dextromethorphan
  • Paracetamol 500mg

Dosage Form: Capsule

Day Capsule

Active Ingredients:

  • Dextromethorphan hydrobromide monohydrate 10mg equivalent to 7.3mg dextromethorphan
  • Paracetamol 500mg
  • Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine

Dosage Form: Capsule

New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited

Manufacturer: Pfizer Australia Pty Limited, New South Wales, Australia

Product: Coldrex Hot Remedy Cold & Flu Hot Lemon

Active Ingredient: Paracetamol 1000mg

Dosage Form: Powder for oral solution

New Zealand Sponsor: GlaxoSmithKline (NZ) Limited

Manufacturer: Smithkline Beecham S.A. Carretera de Ajalvir, Alcal de Henares, Madrid, Spain

Product: Coldrex PE Phenylephrine Cold & Flu Night & Day (Combination Pack)

Night Tablet

Active Ingredients:

  • Chlorphenamine maleate 2mg
  • Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95mg dextromethorphan
  • Paracetamol 500mg
  • Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine

Dosage Form: Tablet

Day Tablet

Active Ingredients:

  • Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95mg dextromethorphan
  • Paracetamol 500mg
  • Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine

Dosage Form: Tablet

New Zealand Sponsor: GlaxoSmithKline (NZ) Limited

Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia

Product: Demazin Paediatric Decongestant Nasal Drops

Active Ingredient: Oxymetazoline hydrochloride 0.25mg/mL

Dosage Form: Nasal drops

New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited

Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan, Xochimilco, Mexico

Product: Drixine Paediatric Decongestant Nasal Drops

Active Ingredient: Oxymetazoline hydrochloride 0.25mg/mL

Dosage Form: Nasal drops

New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited

Manufacturer: Schering-Plough Mexico SA De CV, Xaltocan, Xochimilco, Mexico

Product: Tramedo SR

Active Ingredient: Tramadol hydrochloride 100mg

Dosage Form: Modified release tablet

New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)

Manufacturer: Zentiva AS (Slovakia), Hlohovec, Slovakia



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 1





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
8 January 2009
Medicines Act 1981, New Medicines, Distribution Consent, Pharmaceuticals
  • Minister of Health