✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 118

1 NOVEMBER 2007

3109

Product:
Pegatron Combination Therapy (Combination Product)

Component:
PEG-Intron Redipen

Active Ingredient:
Peginterferon alfa-2b 50Β΅g

Dosage Form:
Powder for injection

Diluent

Manufacturer:
Schering-Plough Limited (Biotechnology Plant), Singapore

Component:
Rebetol Capsule

Active Ingredient:
Ribavirin 200mg

Manufacturer:
Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico

New Zealand Sponsor:
Schering-Plough, a division of Schering-Plough Animal Health Limited

Product:
Pegatron Combination Therapy (Combination Product)

Component:
PEG-Intron Redipen

Active Ingredient:
Peginterferon alfa-2b 80Β΅g

Dosage Form:
Powder for injection

Diluent

Manufacturer:
Schering-Plough Limited (Biotechnology Plant), Singapore

Component:
Rebetol Capsule

Active Ingredient:
Ribavirin 200mg

Manufacturer:
Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico

New Zealand Sponsor:
Schering-Plough, a division of Schering-Plough Animal Health Limited

Dated this 26th day of October 2007.

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

go7536

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:
Tasigna

Active Ingredient:
Nilotinib hydrochloride monohydrate 220.6mg equivalent to 200mg nilotinib

Dosage Form:
Capsule

New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector

Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland

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

Dated this 26th day of October 2007.

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

go7537

Consent to the Distribution of a New Medicine

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

Schedule

Product:
Venofundin 6%

Active Ingredients:
Poly-O-(2-hydroxyethyl)-starch 60g
Sodium chloride 9g

Dosage Form:
Solution for infusion

New Zealand Sponsor:
B Braun New Zealand Pty Limited

Manufacturer:
B Braun Medical S.A., Crissier, Switzerland

Dated this 26th day of October 2007.

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

go7535

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:



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 118


Gazette.govt.nz PDF NZ Gazette 2007, No 118





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
26 October 2007
Medicines Act 1981, Distribution Consent, Changed Medicines, Pegatron Combination Therapy, PEG-Intron Redipen, Peginterferon alfa-2b, Rebetol Capsule, Ribavirin
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

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

πŸ₯ Health & Social Welfare
26 October 2007
Medicines Act 1981, Provisional Consent, New Medicine, Tasigna, Nilotinib hydrochloride monohydrate
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
26 October 2007
Medicines Act 1981, Distribution Consent, New Medicine, Venofundin 6%, Poly-O-(2-hydroxyethyl)-starch, Sodium chloride
  • 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
26 October 2007
Medicines Act 1981, Provisional Consent Renewal, New Medicine
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate