✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 110

6 SEPTEMBER 2012


Product: Panadol Extra Advance (Pharmacy Only)
Active Ingredients: Caffeine 65mg
Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Waterford, Ireland

Dated this 29th day of August 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, 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: DP-Enalapril
Active Ingredient: Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Cadila Pharmaceuticals Limited, Gujarat State, India

Product: DP-Enalapril
Active Ingredient: Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Cadila Pharmaceuticals Limited, Gujarat State, India

Product: DP-Enalapril
Active Ingredient: Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Cadila Pharmaceuticals Limited, Gujarat State, India

Product: Mupider
Active Ingredient: Mupirocin 20mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: Kleva SA, Athens, Greece

Product: Reclens Eye Wash
Active Ingredients: Monobasic potassium phosphate 6.8mg/mL
Sodium chloride 5.7mg/mL
Dosage Form: Eye irrigation
New Zealand Sponsor: Tollot Pty Limited t/a Aaxis Pacific
Manufacturer: Opto-Pharm Pte Limited, Singapore

Product: Spren 100
Active Ingredient: Aspirin 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (New Zealand) Limited t/a Healthcare Logistics
Manufacturer: Aspen Pharma Pty Limited, Dandenong, Australia

Dated this 29th day of August 2012.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 110





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
29 August 2012
Medicines Act 1981, New medicines, Panadol Extra Advance, DP-Enalapril, Mupider, Reclens Eye Wash, Spreen 100, GlaxoSmithKline, Douglas Pharmaceuticals, ABM Pharma, Tollot Pty, Pharmacy Retailing
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health