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: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Buprenorphine Naloxone BNM Buprenorphine hydrochloride 2.16mg equivalent to buprenorphine 2mg Naloxone hydrochloride dihydrate 0.61mg equivalent to naloxone 0.5mg Sublingual tablet Boucher & Muir (New Zealand) Limited t/a BNM Group G.L. Pharma GmbH, Lannach, Austria
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Buprenorphine Naloxone BNM Buprenorphine hydrochloride 8.64mg equivalent to buprenorphine 8mg Naloxone hydrochloride dihydrate 2.44mg equivalent to naloxone 2mg Sublingual tablet Boucher & Muir (New Zealand) Limited t/a BNM Group G.L. Pharma GmbH, Lannach, Austria
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Jinarc Tolvaptan 15mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Otsuka Pharmaceutical Co Limited, Tokushima, Japan
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Jinarc Tolvaptan 30mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Otsuka Pharmaceutical Co Limited, Tokushima, Japan
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Product: Component 1: Active Ingredient: Dosage Form: Component 2: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Jinarc (Combination Product)
Tolvaptan 15mg Tablet
Tolvaptan 45mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Otsuka Pharmaceutical Co Limited, Tokushim, Japan
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Product: Component 1: Active Ingredient: Dosage Form: Component 2: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Jinarc (Combination Product)
Tolvaptan 30mg Tablet
Tolvaptan 60mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Otsuka Pharmaceutical Co Limited, Tokushim, Japan
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Product: Component 1: Active Ingredient: Dosage Form: Component 2: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Jinarc (Combination Product)
Tolvaptan 30mg Tablet
Tolvaptan 90mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Otsuka Pharmaceutical Co Limited, Tokushim, Japan
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Product: Component 1: Active Ingredients:
Dosage Form: Component 2: Active Ingredients:
Dosage Form: Component 3: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Plenvu
Macrogol 3350 100g Potassium chloride 1g Sodium chloride 2g Sodium sulfate 9g Powder for oral solution
Macrogol 3350 40g Potassium chloride 1.2g Sodium chloride 3.2g Powder for oral solution
Ascorbic acid 7.54g Sodium ascorbate 48.11g Powder for oral solution CARSL Consulting Norgine (UK) Limited, Hengoed, United Kingdom
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Dated this 13th day of May 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).