✨ Medicines Approval Notices




NEW ZEALAND GAZETTE, No. 65 β€” 11 JUNE 2015

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).

2015-go3359

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:

Nivestim
Filgrastim 0.12mg
Solution for injection
Hospira NZ Limited
Hospira Zagreb d.o.o., Zagreb, Croatia
Hospira Zagreb d.o.o., Prigorje Brdovecko, Croatia

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

Nivestim
Filgrastim 0.3mg
Solution for injection
Hospira NZ Limited
Hospira Zagreb d.o.o., Zagreb, Croatia
Hospira Zagreb d.o.o., Prigorje Brdovecko, Croatia

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

Nivestim
Filgrastim 0.48mg
Solution for injection
Hospira NZ Limited
Hospira Zagreb d.o.o., Zagreb, Croatia
Hospira Zagreb d.o.o., Prigorje Brdovecko, Croatia

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).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 65





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
4 June 2015
Medicines, Distribution, Consent, Medicines Act 1981, Rixubis, TdaP-Booster, Zaida 3/20
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
4 June 2015
Medicines, Distribution, Consent, Medicines Act 1981, Nivestim
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health