β¨ 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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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare4 June 2015
Medicines, Distribution, Consent, Medicines Act 1981, Rixubis, TdaP-Booster, Zaida 3/20
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare4 June 2015
Medicines, Distribution, Consent, Medicines Act 1981, Nivestim
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2015, No 65