✨ Medicine Distribution Consents




3222 NEW ZEALAND GAZETTE, No. 124 7 AUGUST 2008

Product: Polio Sabin (Oral) Multidose
Active Ingredients:
Polio virus type 1 1,000,000CCID50
Polio virus type 2 100,000CCID50
Polio virus type 3 630,957CCID50

Dosage Form: Oral suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers:
GlaxoSmithKline Biologicals SA, Parc de la Noire Epine, Wavre, Belgium
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 1st day of August 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go5652

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following 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: Polio Sabin (Oral) Monodose
Active Ingredients:
Polio virus type 1 1,000,000CCID50
Polio virus type 2 100,000CCID50
Polio virus type 3 316,227CCID50

Dosage Form: mono-dose Oral suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers:
GlaxoSmithKline Biologicals SA, Parc de la Noire Epine, Wavre, Belgium
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 1st day of August 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go5651

Consent to the Distribution of a New Related Product

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related product set out in the Schedule hereto:

Schedule

Product: Close Up Red Gel
Active Ingredients:
Sodium fluoride 0.21%w/w
Triclosan 0.1%w/w

Dosage Form: Toothpaste
New Zealand Sponsor: Kenny Marketing Limited
Manufacturers:
Hindustan Unilever Limited, Kandla Special Economic Zone, Gandhidham, Gujarat, India

Dated this 1st day of August 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go5654

Renewal of 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: Bicillin L-A
Active Ingredient: Benzathine benzylpenicillin tetrahydrate 450mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited
Manufacturers:
King Pharmaceuticals Inc, Rochester, MI, United States of America
Wyeth Pharmaceuticals Inc, West Chester, Pennsylvania, United States of America

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

Dated this 1st day of August 2008.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 124





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
1 August 2008
Medicines, Distribution, Consent, Polio Sabin (Oral) Multidose
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
1 August 2008
Medicines, Distribution, Consent, Polio Sabin (Oral) Monodose
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to the Distribution of a New Related Product

πŸ₯ Health & Social Welfare
1 August 2008
Medicines, Distribution, Consent, Close Up Red Gel
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
1 August 2008
Medicines, Distribution, Consent, Bicillin L-A
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate