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-Lisinopril
Active Ingredient: Lisinopril dihydrate 10.89mg equivalent to Lisinopril 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Apo-Lisinopril
Active Ingredient: Lisinopril dihydrate 21.78mg equivalent to Lisinopril 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: Apo-Lisinopril
Active Ingredient: Lisinopril dihydrate 5.44mg equivalent to Lisinopril 5mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India
Product: ClearNase Allergy 24 Hour
Active Ingredient: Fluticasone propionate 0.05%w/w
Dosage Form: Nasal spray solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: Dipeptiven
Active Ingredient: Alanylglutamine 200mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Pharmatel Fresenius Kabi NZ Limited
Manufacturer: Fresenius Kabi Austria GmbH, Graz, Austria
Product: Irinotecan-Rex
Active Ingredient: Irinotecan hydrochloride 20mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Ketorolac tromethamine
Active Ingredient: Ketorolac trometamol 0.5%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
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 and 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: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 5mg equivalent to ondansetron 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Kurkumbh Village, Taluka - Daund, District-Pune, Maharashtra State, India
Product: Ondansetron
Active Ingredient: Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Kurkumbh Village, Taluka - Daund, District-Pune, Maharashtra State, India
Product: Penicillin G Sodium
Active Ingredient: Benzylpenicillin sodium 2,994mg equivalent to 5MIU benzylpenicillin sodium salt
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited Generics Sector
Manufacturer: Sandoz GmbH, Kundl, Tyrol, Austria
Product: Penicillin G Sodium
Active Ingredient: Benzylpenicillin sodium 5,988mg equivalent to 10MIU benzylpenicillin sodium salt
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited Generics Sector
Manufacturer: Sandoz GmbH, Kundl, Tyrol, Austria
Product: Terbinafine
Active Ingredient: Terbinafine hydrochloride 281.25mg equivalent to 250mg terbinafine
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, Maharashtra, India
Dated this 12th day of October 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).