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 set out in the Schedule hereto:
Schedule
| Product: | Dizole 50 |
| Active Ingredient: | Fluconazole 50mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Nashik, India |
| Product: | Mersynofen (Pharmacy Only) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturer: | Sanofi Vietnam Shareholding Company, Ho Chi Minh City, Vietnam |
| Product: | Mersynofen (General Sale) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturer: | Sanofi Vietnam Shareholding Company, Ho Chi Minh City, Vietnam |
| Product: | Phesgo |
| Active Ingredients: | Pertuzumab 60mg/mL Trastuzumab 60mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F. Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Phesgo |
| Active Ingredients: | Pertuzumab 80mg/mL Trastuzumab 40mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F. Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Spy Agent Green |
| Active Ingredient: | Indocyanine green 25mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Stryker New Zealand Limited |
| Manufacturer: | Patheon Italia SpA, 2° Trav. SX V, Ferentino, Italy |
| Product: | Yuflyma (Pre-filled syringe) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Catalent Belgium SA, Brussels, Belgium |
| Product: | Yuflyma (Pre-filled syringe with needle guard) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Catalent Belgium SA, Brussels, Belgium |
| Product: | Yuflyma (Pre-filled pen) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Catalent Belgium SA, Brussels, Belgium |
Dated this 16th day of September 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).