Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Benadryl Nightime
Active Ingredients: Dextromethorphan hydrobromide 2mg/mL
Diphenhydramine hydrochloride 2.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Pfizer Consumer Healthcare Div. of Pfizer Laboratories Ltd
Manufacturer: Pfizer Pty Limited, Caringbah, Sydney, New South Wales, Australia
Product: Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 1.193g equivalent to Ceftriaxone 1.0g
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Anfarm Hellas SA, Schimatari, Greece
Product: Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 2.386g equivalent to Ceftriaxone 2.0g
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Anfarm Hellas SA, Schimatari, Greece
Product: Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 298.25mg equivalent to Ceftriaxone 250mg
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Anfarm Hellas SA, Schimatari, Greece
Product: Ceftriaxone Sodium for Injection
Active Ingredient: Ceftriaxone sodium 596.5mg equivalent to Ceftriaxone 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Anfarm Hellas SA, Schimatari, Greece
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1,079.3mg equivalent to 1000mg anhydrous ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 2,158.6mg equivalent to 2000mg anhydrous ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 269.9mg equivalent to 250mg anhydrous ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 539.7mg equivalent to 500mg anhydrous ceftriaxone
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Fervenca, Terrugem - Sintra, Portugal
Product: Implanon
Active Ingredient: Etonogestrel 68mg
Dosage Form: Subcutaneous implant
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Organon International BV, Oss, The Netherlands
Product: i-Profen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Dated this 12th day of June 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).