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: 0.9% Sodium Chloride
Active Ingredient: Sodium chloride 9g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Corporation, North Carolina, United States of America
Product: 5% Glucose
Active Ingredient: Glucose monohydrate 50g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Corporation, North Carolina, United States of America
Product: Calistat
Active Ingredient: Orlistat 120mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra, India
Product: Cetirizine tablets 10mg
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Imatis
Active Ingredient: Imatinib mesilate 119.5mg equivalent to Imatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Imatis
Active Ingredient: Imatinib mesilate 478mg equivalent to Imatinib 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Ipca-Cetirizine
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Prochlorperazine (Restricted)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Prochlorperazine (Prescription)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: iQuit
Active Ingredient: Nicotine 15.76mg releasing Nicotine 7mg in 24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Aveva Drug Delivery Systems Inc, Florida, United States of America
Product: iQuit
Active Ingredient: Nicotine 31.51mg releasing Nicotine 14mg in 24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Aveva Drug Delivery Systems Inc, Florida, United States of America
Product: iQuit
Active Ingredient: Nicotine 47.27mg releasing Nicotine 21mg in 24 hours
Dosage Form: Transdermal patch
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Aveva Drug Delivery Systems Inc, Florida, United States of America
Product: Mycamine
Active Ingredient: Micafungin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: bioCSL (NZ) Limited
Manufacturer: Astellas Pharma Tech Co Limited, Toyama, Japan
Product: Mycamine
Active Ingredient: Micafungin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: bioCSL (NZ) Limited
Manufacturer: Astellas Pharma Tech Co Limited, Toyama, Japan
Product: Nausafix (Restricted)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Nausafix (Prescription)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 15mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 30mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 60mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: OxyContin
Active Ingredient: Oxycodone hydrochloride 80mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Purdue Pharmaceuticals L.P, North Carolina, United States of America
Product: Prochol (Restricted)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Prochol (Prescription)
Active Ingredient: Prochlorperazine maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: ZISTA
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Dated this 8th day of May 2014.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister
of Health on 11 September 2013).