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 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).