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:
Manufacturers:

Avigra
Sildenafil citrate 35.112mg equivalent to Sildenafil 25mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Avigra
Sildenafil citrate 70.225mg equivalent to Sildenafil 50mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Avigra
Sildenafil citrate 140.45mg equivalent to Sildenafil 100mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

Product:
Component 1:
Active Ingredients:








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

Infanrix-hexa

Diphtheria toxoid, adsorbed 30IU
Hepatitis B surface antigen, recombinant 10mcg
Pertactin 8mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 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 type b vaccine 10mcg
Powder for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France
GlaxoSmithKline Biologicals SA, Wavre, Belgium

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

Sildenafil Pfizer
Sildenafil citrate 35.112mg equivalent to Sildenafil 25mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Sildenafil Pfizer
Sildenafil citrate 70.225mg equivalent to Sildenafil 50mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Sildenafil Pfizer
Sildenafil citrate 140.45mg equivalent to Sildenafil 100mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Viagra
Sildenafil citrate 35.112mg equivalent to Sildenafil 25mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Viagra
Sildenafil citrate 70.225mg equivalent to Sildenafil 50mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Viagra
Sildenafil citrate 140.45mg equivalent to Sildenafil 100mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Vivera
Sildenafil citrate 35.112mg equivalent to Sildenafil 25mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Vivera
Sildenafil citrate 70.225mg equivalent to Sildenafil 50mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

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

Vivera
Sildenafil citrate 140.45mg equivalent to Sildenafil 100mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Australia Pty Limited, West Ryde, Australia
Fareva Amboise, Poce Sur Cisse, France

Dated this 13th day of November 2015.

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