✨ Medicines Consent Notices




24 MAY

NEW ZEALAND GAZETTE

1179

Product:
Puff (Verry Berry)

Active Ingredient(s):
Hydrofluoric acid 9.5mg/g
Sodium fluoride 18.5mg/g equivalent to 1.23%w/w fluoride ion

Dosage Form:
Foam

New Zealand Sponsor:
Ivoclar Vivadent Limited

Manufacturer(s):
Pascal Company Inc, Bellevue, Washington, United States of America

Product:
Refresh Tears Plus

Active Ingredient(s):
Carmellose sodium 5mg/mL

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
Allergan New Zealand Limited

Manufacturer(s):
Allergan America, Hormigueros, Puerto Rico

Product:
Reminyl

Active Ingredient(s):
Galantamine hydrobromide 5.124mg/mL equivalent to 4mg/mL galantamine base

Dosage Form:
Oral solution

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer(s):
Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy

Product:
Reminyl

Active Ingredient(s):
Galantamine hydrobromide 15.38mg equivalent to 12mg galantamine base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer(s):
Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy

Product:
Reminyl

Active Ingredient(s):
Galantamine hydrobromide 5.127mg equivalent to 4mg galantamine base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer(s):
Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy

Product:
Reminyl

Active Ingredient(s):
Galantamine hydrobromide 10.254mg equivalent to 8mg galantamine base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Janssen-Cilag Pty Limited

Manufacturer(s):
Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy

Product:
Shield Gold

Active Ingredient(s):
Nonoxinol 9 25mg

Dosage Form:
Condom with spermicide

New Zealand Sponsor:
Medisafe Limited

Manufacturer(s):
Pleasure Latex Products Sdn. Bhn, Jeram, Selangor Darul Ehsan, Malaysia

Product:
Trizivir

Active Ingredient(s):
Abacavir sulphate 351mg equivalent to 300mg abacavir
Lamivudine 150mg
Zidovudine 300mg

Dosage Form:
Tablet

New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited

Manufacturer(s):
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom

Product:
Ziagen

Active Ingredient(s):
Abacavir sulphate 23.4mg/mL equivalent to 20mg/ml abacavir base.

Dosage Form:
Oral solution

New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited

Manufacturer(s):
Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom

Product:
Ziagen

Active Ingredient(s):
Abacavir sulphate 351mg equivalent to 300mg abacavir per tablet

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited

Manufacturer(s):
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom

Dated this 16th day of May 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 52


Gazette.govt.nz PDF NZ Gazette 2001, No 52





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
16 May 2001
Medicines Act 1981, new medicines, distribution consent, Puff, Refresh Tears Plus, Reminyl, Shield Gold, Trizivir, Ziagen
  • G. R. Boyd, Chief Advisor, Safety and Regulation