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 - Oxycodone
Active Ingredient: Oxycodone hydrochloride 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: CP Pharmaceuticals Limited, Wrexham, United Kingdom
Product: CalSource Ca1200+D
Active Ingredients: Calcium carbonate 2100mg equivalent to Elemental calcium 840.8mg
Calcium lactate gluconate 2716mg equivalent to Clemental calcium 359.2mg
Colecalciferol 20µg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Famar France, Orleans Cedex, France
Product: Pamidronate BNM
Active Ingredient: Pamidronic acid 12.63mg/5mL equivalent to Disodium pamidronate 15mg/5mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Hikma Italia S.P.A, Pavia, Italy
Product: Pamidronate BNM
Active Ingredient: Pamidronic acid 25.27mg/10mL equivalent to Disodium pamidronate 30mg/10mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Hikma Italia S.P.A, Pavia, Italy
Product: Pamidronate BNM
Active Ingredient: Pamidronic acid 50.54mg/10mL equivalent to Disodium pamidronate 60mg/10mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Hikma Italia S.P.A, Pavia, Italy
Product: Pamidronate BNM
Active Ingredient: Pamidronic acid 75.82mg/10mL equivalent to Disodium pamidronate 90mg/10mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Hikma Italia S.P.A, Pavia, Italy
Dated this 23rd day of May 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).