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).