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: AmoxiClav BNM
Active Ingredients: Amoxicillin trihydrate 28.7mg/mL equivalent to amoxicillin 125mg/5mL
Potassium clavulanate 15.8mg/mL equivalent to clavulanic acid 31.25mg/5mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Haupt Pharma Latina SRL, Latina, Italy
   
Product: AmoxiClav BNM
Active Ingredients: Amoxicillin trihydrate 57.4mg/mL equivalent to amoxicillin 250mg/5mL
Potassium clavulanate 31.6mg/mL equivalent to clavulanic acid 62.5mg/5mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Haupt Pharma Latina SRL, Latina, Italy
   
Product: Cipla Icatibant
Active Ingredient: Icatibant acetate 10.46mg/mL equivalent to icatibant 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Gland Pharma Limited, Hyderabad, India
   
Product: FLUCELVAX QUAD
Active Ingredient: Influenza vaccine, inactivated, split virion 60mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturers: Seqirus Inc., North Carolina, United States of America
CSL Behring GmbH, Marburg, Germany
   
Product: Rebif (22mcg/0.5mL)
Active Ingredient: Interferon beta-1a 44mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy
   
Product: Rebif (44mcg/0.5mL)
Active Ingredient: Interferon beta-1a 88mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy
   
Product: Rebif (66mcg/1.5mL)
Active Ingredient: Interferon beta-1a 44mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy
   
Product: Rebif (132mcg/1.5mL)
Active Ingredient: Interferon beta-1a 88mcg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SpA, Bari, Italy


Dated this 2nd day of November 2021.

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