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: | Dimethyl Fumarate Viatris |
| Active Ingredient: | Dimethyl fumarate 120mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Pithampur, India |
| Product: | Dimethyl Fumarate Viatris |
| Active Ingredient: | Dimethyl fumarate 240mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Pithampur, India |
| Product: | Lacosamide Te Arai |
| Active Ingredient: | Lacosamide 10mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Lichtenheldt GmbH, Wahlstedt, Germany |
| Product: | Paracetamol 250mg/5mL |
| Active Ingredient: | Paracetamol 50mg/mL |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Rubicon Research Pvt. Limited, Satara, India |
| Product: | Vegzelma (100mg/1mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Vegzelma (400mg/16mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Vumerity |
| Active Ingredient: | Diroximel fumarate 231mg |
| Dosage Form: | Enteric coated capsule |
| New Zealand Sponsor: | Biogen NZ Biopharma Limited |
| Manufacturer: | Alkermes Pharma Ireland Limited, Athlone, Ireland |
Dated this 23rd day of January 2024.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).