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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: | Alphamox 125 |
Active Ingredient: | Amoxicillin trihydrate 26.2mg/mL equivalent to amoxicillin 25mg/mL |
Dosage Form: | Powder for oral suspension |
New Zealand Sponsor: | Viatris Limited |
Manufacturer: | Medreich Limited, Bangalore, India |
Product: | Alphamox 250 |
Active Ingredient: | Amoxicillin trihydrate 52.4mg/mL equivalent to amoxicillin 50mg/mL |
Dosage Form: | Powder for oral suspension |
New Zealand Sponsor: | Viatris Limited |
Manufacturer: | Medreich Limited, Bangalore, India |
Product: | Cosentyx |
Active Ingredient: | Secukinumab 150mg |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
Product: | Cosentyx |
Active Ingredient: | Secukinumab 150mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Sandoz GmbH, Langkampfen, Austria |
Product: | Darzalex SC |
Active Ingredient: | Daratumumab 120mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
Product: | Havrix 1440 vaccine |
Active Ingredient: | Hepatitis A vaccine 1440EU/mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturer: | GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Product: | Havrix Junior |
Active Ingredient: | Hepatitis A vaccine 1440EU/mL equivalent to 720EU/0.5mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturer: | GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Product: | Humalog |
Active Ingredient: | Insulin lispro 100U/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
Manufacturer: | Eli Lilly and Co Inc, Indiana, United States of America |
Product: | Humalog |
Active Ingredient: | Insulin lispro 100U/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
Manufacturers: | Lilly France SAS, Fegersheim, France Eli Lilly Italia Spa, Florence, Italy |
Product: | Humalog Mix25 |
Active Ingredient: | Insulin lispro 100U/mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
Manufacturers: | Eli Lilly and Co Inc, Indiana, United States of America Lilly France SAS, Fegersheim, France Eli Lilly Italia SpA, Florence, Italy |
Product: | Humalog Mix50 |
Active Ingredient: | Insulin lispro 100U/mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
Manufacturers: | Eli Lilly and Co Inc, Indiana, United States of America Lilly France SAS, Fegersheim, France Eli Lilly Italia Spa, Florence, Italy |
Product: | Intelence |
Active Ingredient: | Etravirine 100mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturer: | Janssen-Cilag SpA, Latina, Italy |
Product: | Intelence |
Active Ingredient: | Etravirine 200mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturer: | Janssen-Cilag SpA, Latina, Italy |
Product: | Tambocor |
Active Ingredient: | Flecainide acetate 50mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturers: | 3M Health Care (UK) Limited, Loughborough, United Kingdom Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Limited), Panoli, India |
Product: | Tambocor |
Active Ingredient: | Flecainide acetate 100mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturers: | 3M Health Care (UK) Limited, Loughborough, United Kingdom Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Limited), Panoli, India |
Product: | Tambocor CR |
Active Ingredient: | Flecainide acetate 100mg |
Dosage Form: | Modified release capsule |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturer: | 3M Health Care (UK) Limited, Loughborough, United Kingdom |
Product: | Tambocor CR |
Active Ingredient: | Flecainide acetate 200mg |
Dosage Form: | Modified release capsule |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturer: | 3M Health Care (UK) Limited, Loughborough, United Kingdom |
Product: | Tambocor CR |
Active Ingredient: | Flecainide acetate 300mg |
Dosage Form: | Modified release capsule |
New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
Manufacturer: | 3M Health Care (UK) Limited, Loughborough, United Kingdom |
Product: | Twinrix |
Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mg/mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (Dresden), Dresden, Germany |
Product: | Twinrix Junior |
Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (Dresden), Dresden, Germany |
Dated this 4th day of May 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).