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: Amlodipine Mesylate
Active Ingredient: Amlodipine mesilate 12.79mg equivalent to amlodipine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Siegfried Limited, Zofingen, Switzerland
Zentiva a.s, Prague, Czech Republic
Product: Amlodipine Mesylate
Active Ingredient: Amlodipine mesilate 6.395mg equivalent to amlodipine 5.0 mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Siegfried Limited, Zofingen, Switzerland
Zentiva a.s, Prague, Czech Republic
Product: Dimetapp Chesty Cough Elixir
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaiphenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Interphil Laboratories Inc, Pittland, Cabuyao, Laguna, Philippines
Product: Lemsip Max Sore Throat Anaesthetic
Active Ingredient: Hexylresorcinol 2.5mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Nestle Australia Limited, Blacktown, New South Wales, Australia
Product: Pacific Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 1,193mg equivalent to 1000mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Product: Pacific Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 2,386mg equivalent to 2000mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Product: Pacific Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 298.3mg equivalent to 250mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Product: Pacific Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 596.05mg equivalent to 500mg ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Lupin Limited, Mandideep, District Raisen, Madhya Pradesh, India
Dated this 17th day of February 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).