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: DBL™ Metronidazole Intravenous Infusion
Active Ingredient: Metronidazole 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: ACS Dobfar Info SA, Campascio, Switzerland
Product: Dexmethsone
Active Ingredient: Dexamethasone 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Bangalore, India
Product: Efavirenz Alphapharm
Active Ingredient: Efavirenz 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Lidocaine-Claris
Active Ingredient: Lidocaine hydrochloride monohydrate 10.66mg/mL equivalent to lidocaine hydrochloride 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Lidocaine-Claris
Active Ingredient: Lidocaine hydrochloride monohydrate 21.32mg/mL equivalent to lidocaine hydrochloride 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Ropibam
Active Ingredient: Ropivacaine hydrochloride, anhydrous 2mg/mL equivalent to ropivacaine 1.77mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy
Haemopharm Biofluids S.R.L, Tovo di Sant’Agata, Italy
Product: Ropibam
Active Ingredient: Ropivacaine hydrochloride, anhydrous 7.5mg/mL equivalent to ropivacaine 6.62mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy
Haemopharm Biofluids S.R.L, Tovo di Sant’Agata, Italy
Product: Ropibam
Active Ingredient: Ropivacaine hydrochloride, anhydrous 10mg/mL equivalent to ropivacaine 8.83mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy
Haemopharm Biofluids S.R.L, Tovo di Sant’Agata, Italy
Product: Xanopan
Active Ingredients: Latanoprost 0.05mg/mL
Timolol maleate 6.83mg/mL equivalent to timolol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Wintac Limited, Karnataka, India
Dated this 19th 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).