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: | Febuxostat multichem |
| Active Ingredient: | Febuxostat 80mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | BLUEPHARMA, Coimbra, Portugal |
| Product: | Febuxostat multichem |
| Active Ingredient: | Febuxostat 120mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | BLUEPHARMA, Coimbra, Portugal |
| Product: | Hospira Methotrexate Injection (7.5mg/0.3mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Hospira Methotrexate Injection (10mg/0.4mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Hospira Methotrexate Injection (15mg/0.6mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Hospira Methotrexate Injection (20mg/0.8mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Hospira Methotrexate Injection (25mg/mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Methoblastin PFS (7.5mg/0.3mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Methoblastin PFS (10mg/0.4mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Methoblastin PFS (15mg/0.6mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Methoblastin PFS (20mg/0.8mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Methoblastin PFS (25mg/mL) |
| Active Ingredient: | Methotrexate 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pharmascience Inc, Candiac, Canada |
| Product: | Nerlynx |
| Active Ingredient: | Neratinib maleate 48.31mg equivalent to neratinib 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Specialised Therapeutics Limited |
| Manufacturer: | Excella GmbH & Co KG, Feucht, Germany |
Dated this 25th day of June 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).