✨ Medicine Approvals




3302

NEW ZEALAND GAZETTE, No. 112

28 SEPTEMBER 2006

Product: Logem
Active Ingredient: Lamotrigine 100mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada

Product: Logem
Active Ingredient: Lamotrigine 200mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada

Product: Logem
Active Ingredient: Lamotrigine 25mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada

Product: Logem
Active Ingredient: Lamotrigine 50mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada

Product: Sodium Cromoglycate Eye Drops
Active Ingredient: Sodium cromoglicate 2%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India

Product: Vivotif Oral
Active Ingredient: Salmonella typhi strain TY21A Berna 2,000 million organisms
Dosage Form: Modified release capsule
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Berna Biotech AG, Berne, Switzerland

Dated this 22nd day of September 2006.

GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go6740

Consent to the Distribution of a New Related Product

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

Schedule

Product: Aveeno Soothing Bath Treatment
Active Ingredient: Oatmeal colloidal 100%w/w
Dosage Form: Powder
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Patheon Inc. Burlington, Ontario, Canada

Dated this 22nd day of September 2006.

GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go6741

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:

Schedule

Product: Xigris
Active Ingredient: Drotrecogin alfa (activated) 20mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: DSM Pharmaceuticals Inc, Greenville, North Carolina, United States of America

Note: This consent is valid for two years from 19 September 2006.



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 112


Gazette.govt.nz PDF NZ Gazette 2006, No 112





✨ LLM interpretation of page content

πŸ₯ Approval of Logem Products

πŸ₯ Health & Social Welfare
22 September 2006
Medicine, Lamotrigine, Chewable/dispersible tablet, Pacific Pharmaceuticals
  • GRAEME GILLESPIE, Acting Deputy Director-General, Public Health

πŸ₯ Approval of Sodium Cromoglycate Eye Drops

πŸ₯ Health & Social Welfare
22 September 2006
Medicine, Sodium cromoglicate, Eye drops, REX Medical
  • GRAEME GILLESPIE, Acting Deputy Director-General, Public Health

πŸ₯ Approval of Vivotif Oral

πŸ₯ Health & Social Welfare
22 September 2006
Medicine, Salmonella typhi, Modified release capsule, CSL New Zealand
  • GRAEME GILLESPIE, Acting Deputy Director-General, Public Health

πŸ₯ Consent to Distribution of Aveeno Soothing Bath Treatment

πŸ₯ Health & Social Welfare
22 September 2006
Medicine, Oatmeal colloidal, Powder, Johnson & Johnson
  • GRAEME GILLESPIE, Acting Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent for Xigris

πŸ₯ Health & Social Welfare
22 September 2006
Medicine, Drotrecogin alfa, Powder for infusion, Eli Lilly
  • GRAEME GILLESPIE, Acting Deputy Director-General, Public Health