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 Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturers:

Influvac Tetra
Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) – like strain 15mcg
Influenza virus B/Brisbane/60/2008 – like strain 15mcg
Influenza virus B/Massachusetts/2/2012 – like strain 15mcg
Suspension for injection
Mylan New Zealand Limited
Abbott Biologicals BV, Olst, Netherlands
Abbott Biologicals BV, Weesp, Netherlands

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

Somatuline Autogel
Lanreotide acetate 77.9mg equivalent to lanreotide 60mg
Solution for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Ipsen Pharma Biotech, Signes, France
Ipsen Pharma Biotech, Marseille, France
Sterigenics Italy S.P.A, Bologne, Italy

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

Somatuline Autogel
Lanreotide acetate 113.6mg equivalent to lanreotide 90mg
Solution for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Ipsen Pharma Biotech, Signes, France
Ipsen Pharma Biotech, Marseille, France
Sterigenics Italy S.P.A, Bologne, Italy

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

Somatuline Autogel
Lanreotide acetate 149.4mg equivalent to lanreotide 120mg
Solution for injection
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Ipsen Pharma Biotech, Signes, France
Ipsen Pharma Biotech, Marseille, France
Sterigenics Italy S.P.A, Bologne, Italy

Dated this 12th day of October 2017.

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