Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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:

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

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

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

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jinarc
Tolvaptan 15mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushima, Japan

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jinarc
Tolvaptan 30mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushima, Japan

Product:
Component 1:
Active Ingredient:

Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:

Manufacturer:

Jinarc (Combination Product)

Tolvaptan 15mg
Tablet

Tolvaptan 45mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushim, Japan

Product:
Component 1:
Active Ingredient:

Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:

Manufacturer:

Jinarc (Combination Product)

Tolvaptan 30mg
Tablet

Tolvaptan 60mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushim, Japan

Product:
Component 1:
Active Ingredient:

Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:

Manufacturer:

Jinarc (Combination Product)

Tolvaptan 30mg
Tablet

Tolvaptan 90mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushim, Japan

Product:
Component 1:
Active Ingredients:




Dosage Form:

Component 2:
Active Ingredients:


Dosage Form:

Component 3:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

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

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).