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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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Difflam Plus Anaesthetic + Antibacterial + Anti-inflammatory (Blackcurrant Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Difflam Plus Anaesthetic + Antibacterial + Anti-inflammatory (Eucalyptus Menthol Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Difflam Plus Anaesthetic + Antibacterial + Anti-inflammatory (Honey and Lemon Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Difflam Plus Anaesthetic + Antibacterial + Anti-inflammatory (Pineapple and Lime Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Difflam Plus Anaesthetic + Antibacterial + Anti-inflammatory (Wild Berry Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 3mg
Dichlorobenzyl alcohol 1.2mg
Lidocaine hydrochloride 4mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Difflam Plus Dry Cough + Antibacterial + Anti-inflammatory (Blackcurrant Flavour Sugar Free)
Active Ingredients: Benzydamine hydrochloride 1.5mg
Cetylpyridinium chloride monohydrate 1.33mg
Pholcodine 5.5mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Unique Pharmaceuticals Laboratories, Daman, India
   
Product: Opdivo
Active Ingredient: Nivolumab 47mg equivalent to 40mg/4mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
   
Product: Opdivo
Active Ingredient: Nivolumab 107mg equivalent to 100mg/10mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
   
Product: Winglore (50mg/10mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Winglore (200mg/40mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Yervoy (50mg/10mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Yervoy (200mg/40mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico


Dated this 5th day of March 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).