✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 32 β€” 26 MARCH 2015

Product:
Pediacel

Active Ingredients:
Diphtheria toxoid, adsorbed 15Lf U
Haemophilus influenzae type b polysaccharide 10mcg
Pertactin 3mcg
Pertussis filamentous haemagglutinin 20mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 20mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20mcg
Tetanus toxoid, adsorbed 5Lf U

Dosage Form:
Suspension for injection

New Zealand Sponsor:
sanofi-aventis new zealand limited

Manufacturer:
Sanofi Pasteur Limited, Ontario, Canada

Dated this 20th day of March 2015.

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

2015-go1720


Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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 which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Pandemrix

Active Ingredient:
Influenza virus Haemagglutinin A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75mcg

Dosage Form:
Suspension for injection

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturers:
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Note: This consent is valid to 31 July 2016.

Dated this 20th day of March 2015.

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

2015-go1721


Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
RiaSTAP

Active Ingredient:
Fibrinogen 900mg – 1300mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
CSL Behring (NZ) Limited

Manufacturer:
CSL Behring GmbH, Marburg, Germany

Note: This renewed consent is valid for two years from 12 May 2015.

Dated this 20th day of March 2015.

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

2015-go1722

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 32





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Pediacel

πŸ₯ Health & Social Welfare
20 March 2015
Medicines, Distribution, Consent, Vaccine, Pediacel
  • SARAH READER, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of Pandemrix

πŸ₯ Health & Social Welfare
20 March 2015
Medicines, Distribution, Provisional Consent, Vaccine, Pandemrix
  • SARAH READER, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of RiaSTAP

πŸ₯ Health & Social Welfare
20 March 2015
Medicines, Distribution, Renewal of Provisional Consent, RiaSTAP
  • SARAH READER, Acting Group Manager, Medsafe, Ministry of Health