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: Ethics Enalapril
Active Ingredient: Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Ethics Enalapril
Active Ingredient: Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Ethics Enalapril
Active Ingredient: Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Ibuprofen
Active Ingredient: Ibuprofen 2%
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Meditab Specialities Pvt Limited, Maharashtra, India
Product: Influvac Junior
Active Ingredients: Influenza virus A/California/7/2009 (H1N1) - like strain 7.5mcg
Influenza virus A/Perth/16/2009 (H3N2) - like strain 7.5mcg
Influenza virus B/Brisbane/60/2008 - like strain 7.5mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Biologicals BV, Olst, Netherlands
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Enalapril
Active Ingredient: Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Kadcyla
Active Ingredient: Trastuzumab emtansine 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Product: Kadcyla
Active Ingredient: Trastuzumab emtansine 160mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Dated this 19th day of September 2013.
DR DON MACKIE, 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).