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: Arrow - Zopiclone
Active Ingredient: Zopiclone 3.75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Arrow - Zopiclone
Active Ingredient: Zopiclone 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Boston Kit
Boston Rewetting Drops
Active Ingredients: Chlorhexidine gluconate 0.06mg/mL
Disodium edetate dihydrate 0.56mg/mL
Dosage Form: Eye drops solution
Boston Advance Cleaner
Active Ingredients: Alkyl ether sulfates 263.1mg/mL
Ethoxylated alkyl phenol 3.57mg/mL
Dosage Form: Contact lens solution
Boston Advance Conditioning Solution
Active Ingredients: Chlorhexidine gluconate 0.033mg/mL
Disodium edetate dihydrate 0.5mg/mL
Polihexanide 0.0055mg/mL
Dosage Form: Contact lens solution
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturer: Bausch & Lomb Inc, South Carolina, United States of America
Product: Cefepime-AFT
Active Ingredient: Cefepime dihydrochloride monohydrate 595mg equivalent to Cefepime 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical Co Limited, Shandong Province, China
Product: Cefepime-AFT
Active Ingredient: Cefepime dihydrochloride monohydrate 1.189g equivalent to Cefepime 1g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical Co Limited, Shandong Province, China
Product: Cefepime-AFT
Active Ingredient: Cefepime dihydrochloride monohydrate 2.378g equivalent to Cefepime 2g
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical Co Limited, Shandong Province, China
Product: Codral All-In-One Cough, Cold & Flu Day & Night
Day Capsule
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg equivalent to Dextromethorphan 7.3mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to Phenylephrine 4.1mg
Night Capsule
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg equivalent to Dextromethorphan 7.3mg
Paracetamol 500mg
Chlorphenamine maleate 2mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Product: Donepezil Actavis
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Donepezil Actavis
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Gacet
Active Ingredient: Paracetamol 250mg
Dosage Form: Suppository
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Bliss GVS Pharma Limited, Maharashtra, India
Product: Gacet
Active Ingredient: Paracetamol 500mg
Dosage Form: Suppository
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Bliss GVS Pharma Limited, Maharashtra, India
Product: Hypnozone
Active Ingredient: Zopiclone 3.75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Hypnozone
Active Ingredient: Zopiclone 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Donepezil
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Donepezil
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Metoclopramide
Active Ingredient: Metoclopramide hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Metoclopramide
Active Ingredient: Metoclopramide hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Zopiclone
Active Ingredient: Zopiclone 3.75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA-Zopiclone
Active Ingredient: Zopiclone 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Ledermix
Active Ingredients: Demeclocycline hydrochloride 20mg/g
Triamcinolone acetonide 6.7mg/g
Dosage Form: Powder, dental cement
New Zealand Sponsor: Ozdent (New Zealand) Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany
Product: Ledermix
Active Ingredients: Demeclocycline hydrochloride 30mg/g
Triamcinolone acetonide 10mg/g
Dosage Form: Paste, dental cement
New Zealand Sponsor: Ozdent (New Zealand) Limited
Manufacturer: Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany
Product: Metoclopramide Actavis 5
Active Ingredient: Metoclopramide hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Metoclopramide Actavis 10
Active Ingredient: Metoclopramide hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Nausemed
Active Ingredient: Metoclopramide hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Nausemed
Active Ingredient: Metoclopramide hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Nicabate Gum
Active Ingredient: Nicotine polacrilex 11.78mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Nicabate Gum
Active Ingredient: Nicotine polacrilex 23.56mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark
Product: Zeimer
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Zeimer
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Dated this 16th day of May 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister
of Health on 11 September 2013).