Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Aclovax (General sale)
Active Ingredient: Aciclovir 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Aclovax (Pharmacy only)
Active Ingredient: Aciclovir 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Arrow - Pantop
Active Ingredient: Pantoprazole sodium sesquihydrate 45.112mg equivalent to Pantoprazole 40mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Goa, India
Product: AS-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Colgate NeutraFluor 5000 Gel
Active Ingredient: Sodium fluoride 1.105%w/w equivalent to Fluoride 5000ppm
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate Oral Pharmaceuticals, Texas, United States of America
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 6.94mg equivalent to Amlodipine 5mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 6.94mg equivalent to Amlodipine 5mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 320mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Gemcitabine-PF
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Opti-Free PureMoist
Active Ingredients: Myristamidopropyl dimethylamine 0.0006%w/v
Polidronium chloride 0.001%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Laboratories Inc, Texas, United States of America
Dated this 27th day of September 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).