β¨ 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).
Next Page →
Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2001, No 52
Gazette.govt.nz —
NZ Gazette 2001, No 52
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare16 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