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: Amiodarone Hydrochloride 50 mg/mL
Active Ingredient: Amiodarone hydrochloride 50mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Fisiopharma SrL, Palomonte, Italy
Product: Auro-Simvastatin 5
Active Ingredient: Simvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Simvastatin 10
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Simvastatin 20
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Simvastatin 40
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Simvastatin 80
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Otrivin Plus
Active Ingredients: Ipratropium bromide 0.6mg/mL
Xylometazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland
Product: Reclens MPS
Active Ingredient: Polihexanide 0.0001%
Dosage Form: Contact lens solution
New Zealand Sponsor: Tollot Pty Limited t/a Aaxis Pacific
Manufacturer: Opto-Pharm Pte Limited, Singapore
Product: Simvastatin Pfizer
Active Ingredient: Simvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Simvastatin Pfizer
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Simvastatin Pfizer
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Simvastatin Pfizer
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Simvastatin Pfizer
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Dated this 25th day of February 2011.
STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).