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-Levetiracetam
Active Ingredient: Levetiracetam 250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Levetiracetam
Active Ingredient: Levetiracetam 500mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Levetiracetam
Active Ingredient: Levetiracetam 750mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Levetiracetam
Active Ingredient: Levetiracetam 1000mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Concentrated Haemodialysis Solution AC-F 2135G - Part A
Active Ingredients: Acetic acid 11.2g/L
Calcium chloride dihydrate 6.7g/L
Glucose 69.4g/L
Magnesium chloride hexahydrate 3.6g/L
Potassium chloride 5.2g/L
Sodium chloride 214.8g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited (NZ)
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Concentrated Haemodialysis Solution Formula K1D - Part A
Active Ingredients: Acetic acid 8.4g/L
Calcium chloride dihydrate 6.7g/L
Glucose 70g/L
Magnesium chloride hexahydrate 1.4g/L
Potassium chloride 2.6g/L
Sodium chloride 210.7g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited (NZ)
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Easitrav
Active Ingredient: Cyclizine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Etoposide
Active Ingredient: Etoposide 20mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Glypressin
Active Ingredient: Terlipressin 0.85mg equivalent to terlipressin diacetate 1mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Zentiva AS (Czech Republic), Prague, Czech Republic
Product: Silagra
Active Ingredient: Sildenafil citrate 35.12mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Silagra
Active Ingredient: Sildenafil citrate 70.24mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Silagra
Active Ingredient: Sildenafil citrate 140.48mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Your Pharmacy Congested Cold & Cough Medicine
Active Ingredients: Brompheniramine maleate 0.4mg/mL
Dextromethorphan hydrobromide monohydrate 2mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 13th day of July 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).