✨ Medicines Distribution Consent




NEW ZEALAND GAZETTE

No. 7


Health

Medicines Act 1981

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: Paracare
Active Ingredient: Paracetamol 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland

Dated this 16th day of January 2003.

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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Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Oxis Turbuhaler
Active Ingredient: Formoterol fumarate 12Β΅g/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden

Product: Oxis Turbuhaler
Active Ingredient: Formoterol fumarate 6Β΅g/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden

Product: Tequin
Active Ingredient: Gatifloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Abbott Laboratories Inc, North Chicago, Illinois, United States of America

Product: Tequin
Active Ingredient: Gatifloxacin 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Caribbean Inc, Mayaguez, Puerto Rico

Product: Tequin
Active Ingredient: Gatifloxacin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Puerto Rico Inc., Humacao, Puerto Rico

Product: Tequin
Active Ingredient: Gatifloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Puerto Rico Inc., Humacao, Puerto Rico



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2003, No 7


Gazette.govt.nz PDF NZ Gazette 2003, No 7





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
16 January 2003
Medicines, Distribution, Paracare, Paracetamol, PSM Healthcare Limited
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
16 January 2003
Medicines, Distribution, Oxis Turbuhaler, Tequin, Gatifloxacin, AstraZeneca, Bristol-Myers Squibb
  • G. R. Boyd, Chief Advisor, Safety and Regulation