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:
Manufacturer:

Albey Bee Venom
Bee venom 550mcg
Powder for injection with diluent
Ebos Group Limited
Jubilant Hollister-Stier LLC, Washington, United States of America

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

Albey Paper Wasp Venom
Wasp venom protein 550mcg
Powder for injection with diluent
Ebos Group Limited
Jubilant Hollister-Stier LLC, Washington, United States of America

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

Albey Yellow Jacket Venom
Wasp venom protein 550mcg
Powder for injection with diluent
Ebos Group Limited
Jubilant Hollister-Stier LLC, Washington, United States of America

Product:
Active Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturer:

Fluarix Tetra
Influenza virus A/California/7/2009 (H1N1) like strain 15mcg
Influenza virus A/Texas/50/2012 (H3N2) like strain 15mcg
Influenza virus B/Massachusetts/2/2012 like strain 15mcg
Influenza virus B/Yamagata 16/88 15mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany

Product:
Component 1:

Active Ingredients:




Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Infanrix-Hib vaccine

Detoxified pertussis toxin 25mcg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Tetanus toxoid 40IU
Suspension for injection

Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Manufacturing SpA, Parma, Italy
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France

Product:
Component 1:
Active Ingredients:







Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Infanrix-IPV+Hib

Detoxified pertussis toxin 25mcg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU
Suspension for injection

Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
GlaxoSmithKline Manufacturing SpA, Parma, Italy
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France

Product:
Active Ingredients:









Dosage Form:
New Zealand Sponsor:
Manufacturers:

Synflorix
Pneumococcal Polysaccharide type 1 1mcg
Pneumococcal Polysaccharide type 14 1mcg
Pneumococcal Polysaccharide type 18C 3mcg
Pneumococcal Polysaccharide type 19F 3mcg
Pneumococcal Polysaccharide type 23F 1mcg
Pneumococcal Polysaccharide type 4 3mcg
Pneumococcal Polysaccharide type 5 1mcg
Pneumococcal Polysaccharide type 6B 1mcg
Pneumococcal Polysaccharide type 7F 1mcg
Pneumococcal Polysaccharide type 9V 1mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France


Dated this 15th 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).