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: Apo - Leflunomide
Active Ingredient: Leflunomide 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Canada
Product: Apo - Leflunomide
Active Ingredient: Leflunomide 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Canada
Product: Cefepime Injection 500mg
Active Ingredients: Cefepime dihydrochloride monohydrate 575.9mg equivalent to 500mg cefepime free base
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India
Product: Cefepime Injection 1g
Active Ingredient: Cefepime dihydrochloride monohydrate 1.1518g equivalent to 1g cefepime free base
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India
Product: Cefepime Injection 2g
Active Ingredient: Cefepime dihydrochloride monohydrate 2.3036g equivalent to 2g cefepime free base
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Patancheru Mandal, India
Product: Codral Relief Cold & Flu
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Colgate Sensitive Enamel Protect Plus Whitening
Active Ingredients: Potassium citrate monohydrate 5.53%w/w
Sodium monofluorophosphate 0.76%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive (Thailand) Limited, Amphur Muang, Thailand
Product: Difflam Anaesthetic, Antibacterial & Anti-inflammatory Sugar Free Berry
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride, anhydrous 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Nestle Australia Limited, Blacktown, Australia
Product: Difflam Anaesthetic, Antibacterial & Anti-inflammatory Sugar Free Menthol & Eucalyptus
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride, anhydrous 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Nestle Australia Limited, Blacktown, Australia
Product: Omezol IV
Active Ingredient: Omeprazole 40mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Sirton Pharmaceuticals S.p.A, Villa Guardia, Italy
Product: Paclitaxel
Active Ingredient: Paclitaxel 6mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Oncotec Pharma Produktion GmbH, Dessau, Germany
Product: Pethidine Injection BP
Active Ingredient: Pethidine hydrochloride 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Romford, United Kingdom
Dated this 26th day of May 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).