Notice Title

Consent to the Distribution of New Medicines

Publication Date
2 Oct 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go5498
Title
View PDF
File Type and Size
PDF (26 KB)

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 are set out in the Schedule hereto:

Schedule

Product: Camzyos
Active Ingredient: Mavacamten 2.5mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Camzyos
Active Ingredient: Mavacamten 5mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Camzyos
Active Ingredient: Mavacamten 10mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Camzyos
Active Ingredient: Mavacamten 15mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Elahere
Active Ingredient: Mirvetuximab soravtansine 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: BSP Pharmaceuticals SpA, Latina Scalo, Italy
   
Product: Fulvestrant
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: Laboratorios Farmalan S.A., Leon, Spain
   
Product: Noumed Ibuprofen for Children 3 Months to 5 Years
Active Ingredient: Ibuprofen 20mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India
   
Product: Pharmacor Rivaroxaban
Active Ingredient: Rivaroxaban 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Pharmacor Rivaroxaban
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Pharmacor Rivaroxaban
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Pharmacor Rivaroxaban
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Rivoxa
Active Ingredient: Rivaroxaban 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Rivoxa
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Rivoxa
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India
   
Product: Rivoxa
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacor Limited
Manufacturer: Inventia Healthcare Limited, Ambernath, India


Dated this 26th day of September 2025.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).