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: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 1,193.7mg equivalent 1g ceftriaxone
Dosage Form: Powder for injection
NZ Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS., Lulebergaz, Kirklareli, Turkey
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 2,387.4mg equivalent 2g ceftriaxone
Dosage Form: Powder for injection
NZ Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS., Lulebergaz, Kirklareli, Turkey
Product: Ceftriaxone
Active Ingredient(s): Ceftriaxone sodium 596.85mg equivalent 500mg ceftriaxone
Dosage Form: Powder for injection
NZ Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Eczacibasi Ilac Sanayi ve Ticaret AS., Lulebergaz, Kirklareli, Turkey
Product: Miflonide
Active Ingredient(s): Budesonide 200µg
Dosage Form: Powder filled inhalation capsule
NZ Sponsor: Novartis New Zealand Limited
Manufacturer(s): Pharmachemie BV, Haarlem, The Netherlands
Product: Miflonide
Active Ingredient(s): Budesonide 400µg
Dosage Form: Powder filled inhalation capsule
NZ Sponsor: Novartis New Zealand Limited
Manufacturer(s): Pharmachemie BV, Zaandam, The Netherlands
Product: Norvir
Active Ingredient(s): Ritonavir 100mg
Dosage Form: Soft gelatin capsule
NZ Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): R P Scherer Corporation, St Petersburg, Florida, United States of America
Product: Norvir
Active Ingredient(s): Ritonavir 100mg
Dosage Form: Capsule
NZ Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories Limited, Queensborough, Kent, England
Abbott Laboratories, Chemical & Agricultural Products Division, North Chicago, Illinois, United States of America
Product: Norvir
Active Ingredient(s): Ritonavir 80mg/mL
Dosage Form: Oral solution
NZ Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories Limited, Queensborough, Kent, England
Abbott Laboratories, Chemical & Agricultural Products Division, North Chicago, Illinois, United States of America
Dated this 12th day of January 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister ofHealth on the 20th day of February 1997).