Medicines Notices




NEW ZEALAND GAZETTE

No. 7

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Iressa

Active Ingredient:
Gefitinib 250mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca UK Ltd, Macclesfield, Cheshire, United Kingdom

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 14th day of January 2004.

CYNTHIA MALING, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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:
Hiberix

Active Ingredient:
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10µg/dose

Dosage Form:
Powder for injection

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium

Product:
Infanrix-Hib vaccine

Component One
(syringe):
Active Ingredients:
Detoxified pertussis toxin 25µg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8µg
Pertussis filamentous haemagglutinin 25µg
Tetanus toxoid 40IU

Dosage Form:
Suspension for injection

Component Two
(vial):
Active Ingredient:
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10µg

Dosage Form:
Powder for injection

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium

Product:
Infanrix-IPV-Hib (Combination Product)

Component One
(syringe):
Active Ingredients:
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid, adsorbed 60IU/mL
Pertactin 16µg/mL
Pertussis filamentous haemagglutinin 50µg/mL
Polio virus type 1 80DAgU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Tetanus toxoid, adsorbed 80IU/mL

Dosage Form:
Suspension for injection

Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium

Component Two
(vial):
Active Ingredient:
Haemophilus influenzae vaccine, tetanus toxoid conjugate 20µg/mL

Dosage Form:
Powder for injection

Manufacturer:
GlaxoSmithKline Biologicals, Rixensart, Belgium

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 7


Gazette.govt.nz PDF NZ Gazette 2004, No 7





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
14 January 2004
Medicines Act 1981, New Medicines, Iressa, Gefitinib, AstraZeneca Limited
  • CYNTHIA MALING, Acting Deputy Director-General, Public Health

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
14 January 2004
Medicines Act 1981, Changed Medicines, Hiberix, Infanrix-Hib vaccine, Infanrix-IPV-Hib, GlaxoSmithKline (NZ) Limited
  • CYNTHIA MALING, Acting Deputy Director-General, Public Health