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:
| Product: | Janssen Abiraterone |
| Active Ingredient: | Abiraterone acetate 250mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Patheon France SA, Bourgoin Jallieu, France Patheon Inc, Mississauga, Canada |
| Product: | Janssen Abiraterone |
| Active Ingredient: | Abiraterone acetate 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Patheon France SA, Bourgoin Jallieu, France |
| Product: | Paracetamol & Ibuprofen Tab (General sale) |
| Active Ingredients: | Ibuprofen 150mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturers: | Sigma Laboratories Private Limited, Mapusa, India Qilu Pharmaceutical Co Limited, Jinan, China Yiling Pharmaceutical Limited (YPL), Shijiazhuang, China |
| Product: | Prochlorperazine maleate (Brown & Bunk) |
| Active Ingredient: | Prochlorperazine maleate 3mg |
| Dosage Form: | Buccal tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Micro Labs Limited, Hosur, India |
| Product: | Prochlorperazine maleate (Max Health) |
| Active Ingredient: | Prochlorperazine maleate 3mg |
| Dosage Form: | Buccal tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Micro Labs Limited, Hosur, India |
| Product: | Suxamethonium (Medicianz) |
| Active Ingredient: | Suxamethonium chloride dihydrate 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Maiva Pharma Private Limited, Hosur, India |
| Product: | Suxamethonium (Medsurge) |
| Active Ingredient: | Suxamethonium chloride dihydrate 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Maiva Pharma Private Limited, Hosur, India |
| Product: | Vicks VapoRub Xtra Strong |
| Active Ingredients: | Eucalyptus oil 3.84%w/w Menthol 7%w/w |
| Dosage Form: | Topical ointment |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Makson Health Care (Private) Limited, Annaram Village, India |
| Product: | Yuflyma (20mg/0.2mL) (Pre-filled syringe) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
| Product: | Yuflyma (80mg/0.8mL) (Pre-filled pen) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
| Product: | Yuflyma (80mg/0.8mL) (Pre-filled syringe) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
| Product: | Yuflyma (80mg/0.8mL) (Pre-filled syringe with safety guard) |
| Active Ingredient: | Adalimumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Pharm Inc, Cheongju-si, South Korea |
Dated this 16th day of December 2024.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).