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 set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Alacare
Aminolevulinic acid hydrochloride 10.2mg
equivalent to aminolevulinic acid 8mg
Dermal patch
Link Pharmaceuticals Limited
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

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

Bisolvon Dry
Dextromethorphan hydrobromide monohydrate 0.2%w/v
Oral solution
Boehringer Ingelheim (NZ) Limited
Delpharm Reims SAS, Reims, France

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

Buscopan Forte
Hyoscine butylbromide 20mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Delpharm Reims SAS, Reims, France

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Kombiglyze XR
Metformin hydrochloride 500mg
Saxagliptin 5mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Kombiglyze XR
Metformin hydrochloride 1000mg
Saxagliptin 5mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Kombiglyze XR
Metformin hydrochloride 1000mg
Saxagliptin 2.5mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Morphine Juno 10mg/1mL
Morphine hydrochloride trihydrate 10mg/mL
equivalent to morphine base 7.58mg/mL

Solution for injection
Juno Pharmaceuticals NZ Limited
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Morphine Juno 20mg/1mL
Morphine hydrochloride trihydrate 20mg/mL
equivalent to morphine base 15.18mg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Morphine Juno 50mg/5mL
Morphine hydrochloride trihydrate 10mg/mL
equivalent to morphine base 7.58mg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Morphine Juno 100mg/5mL
Morphine hydrochloride trihydrate 20mg/mL
equivalent to morphine base 15.18mg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

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

Opdivo 40mg/4mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

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

Opdivo 100mg/10mL
Nivolumab 10mg/mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico

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

Paracetamol Hot Lemon Lime Drink
Paracetamol 500mg
Oral granules
Multichem NZ Limited
Cipla Limited, Pithampur, India

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

Paracetamol Hot Lemon Lime Drink
Paracetamol 1000mg
Oral granules
Multichem NZ Limited
Cipla Limited, Pithampur, India

Dated this 21st day of April 2016.

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