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: Arabloc
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arabloc
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arabloc
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arava
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arava
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Arava
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Citalopram
Active Ingredient: Citalopram hydrobromide 24.99mg equivalent to citalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Citpram
Active Ingredient: Citalopram hydrobromide 24.99mg equivalent to citalopram 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Fexofast 120
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cadila Pharmaceuticals Limited, Dholka, Gujarat State, India
Product: Fexofast 180
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cadila Pharmaceuticals Limited, Dholka, Gujarat State, India
Product: Inosert
Active Ingredient: Sertraline hydrochloride 111.9mg equivalent to 100mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Inosert
Active Ingredient: Sertraline hydrochloride 55.95mg equivalent to 50mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France
Product: Nicorette Softmint Gum
Active Ingredient: Nicotine 2.2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited
Manufacturers: McNeil AB, Helsingborg, Sweden
McNeil Esbjerg ApS, Staerevej, Esbjerg, Denmark
Product: Nicorette Softmint Gum
Active Ingredient: Nicotine 4.4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited
Manufacturers: McNeil AB, Helsingborg, Sweden
McNeil Esbjerg ApS, Staerevej, Esbjerg, Denmark
Product: Nicotrol Softmint Gum
Active Ingredient: Nicotine 2.2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited
Manufacturers: McNeil AB, Helsingborg, Sweden
McNeil Esbjerg ApS, Staerevej, Esbjerg, Denmark
Product: Nicotrol Softmint Gum
Active Ingredient: Nicotine 4.4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson Pacific (New Zealand) Limited
Manufacturers: McNeil AB, Helsingborg, Sweden
McNeil Esbjerg ApS, Staerevej, Esbjerg, Denmark
Product: Pioglitazone
Active Ingredient: Pioglitazone hydrochloride 16.53mg equivalent to 15mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Pioglitazone
Active Ingredient: Pioglitazone hydrochloride 33.07mg equivalent to 30mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Pioglitazone
Active Ingredient: Pioglitazone hydrochloride 49.6mg equivalent to 40mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Sertraline
Active Ingredient: Sertraline hydrochloride 111.9mg equivalent to 100mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Sertraline
Active Ingredient: Sertraline hydrochloride 55.95mg equivalent to 50mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli (U T), India
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 114.3mg equivalent to 100mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Puerto Rico
Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 91.42mg equivalent to 80mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Puerto Rico
Product: Xigris
Active Ingredient: Drotrecogin alfa (activated) 20mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, Greenville, North Carolina, United States of America
Product: Xigris
Active Ingredient: Drotrecogin alfa (activated) 5mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, Greenville, North Carolina, United States of America
Dated this 12th day of February 2009.
STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).