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: DP Finasteride
Active Ingredient: Finasteride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Kern Pharma SL, Terrassa, Barcelona, Spain
Orion Pharma, Espoo, Finland
Product: m-Captopril
Active Ingredient: Captopril 100mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: m-Captopril
Active Ingredient: Captopril 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: m-Captopril
Active Ingredient: Captopril 25mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: m-Captopril
Active Ingredient: Captopril 50mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India
Product: m-Timolol 0.25% w/v
Active Ingredient: Timolol maleate 3.4mg/mL equivalent to timolol 2.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: FDC Limited, Waluj, District Aurangabad, India
Product: m-Timolol 0.5% w/v
Active Ingredient: Timolol maleate 6.8mg/mL equivalent to timolol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: FDC Limited, Waluj, District Aurangabad, India
Product: Prezista
Active Ingredient: Darunavir 300mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
Product: Sertraline-Rex
Active Ingredient: Sertraline hydrochloride 112mg equivalent to 100mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Sertraline-Rex
Active Ingredient: Sertraline hydrochloride 56mg equivalent to 50mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Kurkumbh Village, Taluka - Daund, District - Pune, Maharashtra State, India
Product: SolvEasy Tinea Cream
Active Ingredient: Terbinafine hydrochloride 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia
Product: Veracol
Active Ingredient: Ceftriaxone sodium 2,386mg equivalent to ceftriaxone 2000mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens-Lamia, Kryoneri, Athens, Greece
Product: Veracol
Active Ingredient: Ceftriaxone sodium 1,193mg equivalent to ceftriaxone 1000mg
Dosage Form: Powder for injection
Active Ingredient: Lidocaine hydrochloride monohydrate 37.3mg equivalent to lidocaine 35mg
Dosage Form: Diluent
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens-Lamia, Kryoneri, Athens, Greece
Product: Veracol
Active Ingredient: Ceftriaxone sodium 1,193mg equivalent to ceftriaxone 1000mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens-Lamia, Kryoneri, Athens, Greece
Product: Veracol
Active Ingredient: Ceftriaxone sodium 298mg equivalent to ceftriaxone 250mg
Dosage Form: Powder for injection
Active Ingredient: Lidocaine hydrochloride monohydrate 21.32mg equivalent to lidocaine 20mg
Dosage Form: Diluent
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens-Lamia, Kryoneri, Athens, Greece
Product: Veracol
Active Ingredient: Ceftriaxone sodium 596.5mg equivalent to ceftriaxone 500mg
Dosage Form: Powder for injection
Active Ingredient: Lidocaine hydrochloride monohydrate 21.32mg equivalent to lidocaine 20mg
Dosage Form: Diluent
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens-Lamia, Kryoneri, Athens, Greece
Dated this 17th day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).