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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Amoxil
Amoxicillin trihydrate 292.4mg equivalent to amoxycillin 250mg
Capsule
GlaxoSmithKline (NZ) Limited
Aspen Pharma Pty Limited, Melbourne, Australia
SmithKline Beecham Pharmaceuticals Limited, Worthing, United Kingdom
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Amoxil
Amoxicillin trihydrate 584.8mg equivalent to amoxycillin 500mg
Capsule
GlaxoSmithKline (NZ) Limited
Aspen Pharma Pty Limited, Melbourne, Australia
SmithKline Beecham Pharmaceuticals Limited, Worthing, United Kingdom
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Amoxil forte Syrup
Amoxicillin trihydrate 57.5mg/mL equivalent to amoxycillin 50mg/mL
Powder for oral suspension
GlaxoSmithKline (NZ) Limited
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Amoxil Paediatric Drops
Amoxicillin trihydrate 116.96mg/mL equivalent to amoxcillin 100mg/mL
Powder for oral suspension
GlaxoSmithKline (NZ) Limited
SmithKline Beecham Pharmaceuticals Limited, Worthing, United Kingdom
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Amoxil Syrup
Amoxicillin trihydrate 28.75mg/mL equivalent to amoxycillin 25mg/mL
Powder for oral suspension
GlaxoSmithKline (NZ) Limited
Glaxo Wellcome Production, Mayenne, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Humira
Adalimumab 10mg/0.2mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Humira
Adalimumab 20mg/0.4mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Humira
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Humira Pen
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Aesica Queenborough Limited, Queenborough, United Kingdom
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Dated this 19th day of April 2018.

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