β¨ Medicines Distribution Consent
15 DECEMBER 2005
NEW ZEALAND GAZETTE, No. 207
5271
Product:
Eloxatin
Active Ingredient:
Oxaliplatin 50mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Aventis Pharma Limited
Manufacturer:
Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Laboratoires Thissen SA, Braine-LβAlleud, Belgium
Product:
NovoMix 30 Flexpen
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product:
NovoMix 30 Penfill
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product:
NovoRapid FlexPen
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France
Product:
NovoRapid Penfill
Active Ingredient:
Insulin aspart 100U/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Production S.A.S, Chartres Cedex, France
Product:
NovoRapid
Active Ingredient:
Insulin aspart 100U/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutical Industries Inc., North Carolina, United States of America
Dated this 8th day of December 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
go8344
Renewal of Provisional Consent to the Distribution of New Medicines
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 medicines set out in the Schedule hereto:
Schedule
Product:
Viramune
Active Ingredient:
Nevirapine 200mg
Dosage Form:
Tablet
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturers:
Boehringer Ingelheim Pharmaceuticals Inc, Danbury, Connecticut, United States of America
Boehringer Ingelheim Roxane Inc, Columbus, Ohio, United States of America
Note: This consent is valid for two years from 4 December 2005.
Product:
HyperHep B
Active Ingredient:
Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Bayer New Zealand Limited
Manufacturer:
Talecris Biotherapeutics, Inc., Clayton, North Carolina, United States of America
Note: This consent is valid for two years from 13 December 2005.
Product:
Fabrazyme
Active Ingredient:
Agalsidase beta - rch 35mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:
Genzyme Corporation, Allston, Massachusetts, United States of America
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2005, No 207
Gazette.govt.nz —
NZ Gazette 2005, No 207
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Changed Medicines
(continued from previous page)
π₯ Health & Social Welfare8 December 2005
Medicines Act, Changed Medicines, Distribution, Eloxatin, Oxaliplatin, NovoMix, NovoRapid
- DON MATHESON, Deputy Director-General, Public Health
π₯ Renewal of Provisional Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act, Provisional Consent, Distribution, Viramune, Nevirapine, HyperHep B, Hepatitis B immunoglobulin, Fabrazyme, Agalsidase beta