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: Benadryl Cough & Cold
Active Ingredients: Dextromethorphan hydrobromide monohydrate 2mg/mL
Diphenhydramine hydrochloride 2.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Victoria, Australia
Product: Eutroxsig
Active Ingredient: Levothyroxine sodium, anhydrous 100æg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Product: Eutroxsig
Active Ingredient: Levothyroxine sodium, anhydrous 75æg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Product: Eutroxsig
Active Ingredient: Levothyroxine sodium, anhydrous 200æg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Product: Eutroxsig
Active Ingredient: Levothyroxine sodium, anhydrous 50æg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Dandenong, Australia
Product: Galantyl
Active Ingredient: Galantamine hydrobromide 10.256mg equivalent to galantamine 8mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Galantyl
Active Ingredient: Galantamine hydrobromide 20.512mg equivalent to galantamine 16mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Galantyl
Active Ingredient: Galantamine hydrobromide 30.768mg equivalent to galantamine 24mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Lumigan RC
Active Ingredient: Bimatoprost 0.1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, County Mayo, Ireland
Product: OxyNorm
Active Ingredient: Oxycodone hydrochloride 50mg/mL equivalent to oxycodone base 45mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: Hamol Limited, Nottinghamshire, United Kingdom
Dated this 5th day of February 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).