Gazette.govt.nzPursuant 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).