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: AS-Oxaliplatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: AS-Oxaliplatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: AS-Oxaliplatin
Active Ingredient: Oxaliplatin 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Bupivacaine-Claris
Active Ingredient: Bupivacaine hydrochloride monohydrate 2.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Bupivacaine-Claris
Active Ingredient: Bupivacaine hydrochloride monohydrate 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Caltrate 600mg
Active Ingredient: Calcium carbonate 1.65g equivalent to Calcium 600mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Wyeth Pharmaceutical Co Limited, Jiangsu , China
Product: Decozol
Active Ingredient: Miconazole 2%w/w
Dosage Form: Oral gel
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Hoe Pharmaceuticals Sdn Bhd, Selangor, Malaysia
Product: GN-Oxaliplatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Oxaliplatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Oxaliplatin
Active Ingredient: Oxaliplatin 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Juvederm VOLUMA with Lidocaine
Active Ingredients: Lidocaine hydrochloride 3mg/mL
Sodium hyaluronate 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Pringy, France
Product: Oxaliplatin-PF
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Oxaliplatin-PF
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Oxaliplatin-PF
Active Ingredient: Oxaliplatin 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Saltarelo Holdings Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Dated this 11th day of April 2012.
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).