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A corrigendum to this notice was published on 18 June 2015, Issue No. 68, Notice No. 2015-go3571.

Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
11 Jun 2015

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2015-go3359

Issue Number

65
Title
View PDF
File Type and Size
PDF (22 KB)

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:

RIXUBIS
Nonacog gamma 50IU/mL equivalent to 250IU/vial
Powder for injection
Baxter Healthcare Limited
Baxter Healthcare Corporation, California, United States of America

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

RIXUBIS
Nonacog gamma 100IU/mL equivalent to 500IU/vial
Powder for injection
Baxter Healthcare Limited
Baxter Healthcare Corporation, California, United States of America

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

RIXUBIS
Nonacog gamma 200IU/mL equivalent to 1000IU/vial
Powder for injection
Baxter Healthcare Limited
Baxter Healthcare Corporation, California, United States of America

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

RIXUBIS
Nonacog gamma 400IU/mL equivalent to 2000IU/vial
Powder for injection
Baxter Healthcare Limited
Baxter Healthcare Corporation, California, United States of America

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

RIXUBIS
Nonacog gamma 600IU/mL equivalent to 3000IU/vial
Powder for injection
Baxter Healthcare Limited
Baxter Healthcare Corporation, California, United States of America

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

TdaP-Booster
Diphtheria toxoid, adsorbed 2IU
Pertussis toxoid, adsorbed 20mcg
Tetanus toxoid, adsorbed 20IU
Suspension for injection
bioCSL (NZ) Limited
Statens Serum Institut, Copenhagen, Denmark

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Zaida 3/20
Drospirenone 3mg
Ethinylestradiol 0.02mg
Tablet
Mylan New Zealand Limited
Famy Care Limited, Ahmedabad, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Zaida 3/20
Drospirenone 3mg
Ethinylestradiol 0.03mg
Tablet
Mylan New Zealand Limited
Famy Care Limited, Ahmedabad, India

Dated this 4th day of June 2015.

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