Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981 (“Act”), 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 amoxicillin 250mg
Capsule
GlaxoSmithKline (NZ) Limited
Aspen Pharma Pty Limited, Melbourne, Australia
SmithKline Beecham Pharmaceuticals Limited, West Sussex, United Kingdom
Glaxo Wellcome Production, Mayenne, France

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

Amoxil
Amoxicillin trihydrate 584.8mg equivalent to amoxicillin 500mg
Capsule
GlaxoSmithKline (NZ) Limited
Aspen Pharma Pty Limited, Melbourne, Australia
SmithKline Beecham Pharmaceuticals Limited, West Sussex, 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 amoxicillin 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 amoxicillin 100mg/mL
Powder for oral suspension
GlaxoSmithKline (NZ) Limited
SmithKline Beecham Pharmaceuticals Limited, West Sussex, 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 amoxicillin 25mg/mL
Powder for oral suspension
GlaxoSmithKline (NZ) Limited
Glaxo Wellcome Production, Mayenne, France

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

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Schering-Plough Company, County Cork, Ireland

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

Revlimid
Lenalidomide 5mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

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

Revlimid
Lenalidomide 10mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

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

Revlimid
Lenalidomide 15mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

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

Revlimid
Lenalidomide 25mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Dated this 18th day of April 2017.

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