β¨ 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).
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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).
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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 —
NZ Gazette 2007, No 118
Gazette.govt.nz —
NZ Gazette 2007, No 118
β¨ LLM interpretation of page content
π₯ Consent to the Distribution of Changed Medicines
π₯ Health & Social Welfare26 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
π₯ Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare26 October 2007
Medicines Act 1981, Provisional Consent, New Medicine, Tasigna, Nilotinib hydrochloride monohydrate
- JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare26 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
π₯ Renewal of Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare26 October 2007
Medicines Act 1981, Provisional Consent Renewal, New Medicine
- JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate