Notice Type
Departmental
Notice Title

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:

Schedule

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).