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: Champix 0.5mg and 1mg tablets (Combination Product)
Active Ingredient: Varenicline tartrate 0.85mg equivalent to 0.5mg varenicline
Dosage Form: Film coated tablet
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
New Zealand Sponsor: Pfizer New Zealand Limited
Active Ingredient: Varenicline tartrate 1.71mg equivalent to 1mg varenicline
Dosage Form: Film coated tablet
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
New Zealand Sponsor: Pfizer New Zealand Limited
Product: Champix
Active Ingredient: Varenicline tartrate 0.85mg equivalent to 0.5mg varenicline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
Product: Champix
Active Ingredient: Varenicline tartrate 1.71mg equivalent to 1mg varenicline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
Product: Coldrex PE Phenylephrine Cough, Cold & Flu
Active Ingredients: Guaifenesin 100mg
Paracetamol 250mg
Phenylephrine hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Famar SA, Factory B, Anthoussa, Attiki, Greece
Product: Maxiclear Cold & Flu Relief
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Maxiclear Sinus & Pain Relief
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Viraban
Active Ingredient: Aciclovir 5g/g
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Dated this 2nd day of March 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).