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:
Manufacturers:

Atorvastatin Pacific
Atorvastatin calcium trihydrate 10.844mg equivalent to Atorvastatin 10mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, Maharashtra State, India
Mylan Laboratories Limited, Nashik, Maharashtra State, India

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

Atorvastatin Pacific
Atorvastatin calcium trihydrate 21.688mg equivalent to Atorvastatin 20mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, Maharashtra State, India
Mylan Laboratories Limited, Nashik, Maharashtra State, India

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

Atorvastatin Pacific
Atorvastatin calcium trihydrate 43.376mg equivalent to Atorvastatin 40mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, Maharashtra State, India
Mylan Laboratories Limited, Nashik, Maharashtra State, India

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

Atorvastatin Pacific
Atorvastatin calcium trihydrate 86.751mg equivalent to Atorvastatin 80mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, Maharashtra State, India
Mylan Laboratories Limited, Nashik, Maharashtra State, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Maxiclear PE 2.5 Cold and Flu Relief (General Sale)
Paracetamol 500mg
Phenylephrine hydrochloride 2.5mg
Film coated tablet
AFT Pharmaceuticals Limited
Sigma Laboratories Limited, Goa, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Maxiclear PE 2.5 Cold and Flu Relief (Pharmacy Only)
Paracetamol 500mg
Phenylephrine hydrochloride 2.5mg
Film coated tablet
AFT Pharmaceuticals Limited
Sigma Laboratories Limited, Goa, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Maxiclear PE 2.5 Sinus and Pain Relief (General Sale)
Paracetamol 500mg
Phenylephrine hydrochloride 2.5mg
Film coated tablet
AFT Pharmaceuticals Limited
Sigma Laboratories Limited, Goa, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Maxiclear PE 2.5 Sinus and Pain Relief (Pharmacy Only)
Paracetamol 500mg
Phenylephrine hydrochloride 2.5mg
Film coated tablet
AFT Pharmaceuticals Limited
Sigma Laboratories Limited, Goa, India

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

Signifor
Pasireotide diaspartate 0.3762mg/mL equivalent to Pasireotide 0.3mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Signifor
Pasireotide diaspartate 0.7524mg/mL equivalent to Pasireotide 0.6mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Signifor
Pasireotide diaspartate 1.1286mg/mL equivalent to Pasireotide 0.9mg/mL
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 9th day of July 2015.

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