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: Gaviscon Dual Action
Active Ingredients: Calcium carbonate 32.5mg/mL
Sodium alginate 50mg/mL
Sodium bicarbonate 21.3mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Lemsip Max Flexi Cold & Flu
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to phenylephrine 5mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Targin
Active Ingredients: Naloxone hydrochloride dihydrate 5.45mg equivalent to Naloxone hydrochloride anhydrous 5mg
Oxycodone hydrochloride 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Mundipharma GmbH, Limburg Lahn, Germany
Product: Targin
Active Ingredients: Naloxone hydrochloride dihydrate 10.9mg equivalent to Naloxone hydrochloride anhydrous 10mg
Oxycodone hydrochloride 20mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Mundipharma GmbH, Limburg Lahn, Germany
Product: Targin
Active Ingredients: Naloxone hydrochloride dihydrate 21.8mg equivalent to Naloxone hydrochloride anhydrous 20mg
Oxycodone hydrochloride 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Mundipharma GmbH, Limburg Lahn, Germany
Product: Targin
Active Ingredients: Naloxone hydrochloride dihydrate 2.73mg equivalent to Naloxone hydrochloride anhydrous 2.5mg
Oxycodone hydrochloride 5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturers: Bard Pharmaceuticals Limited, Cambridge, United Kingdom
Mundipharma GmbH, Limburg Lahn, Germany
Dated this 19th day of June 2009.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).