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: Cefuroxime 1500mg
Active Ingredient(s): Cefuroxime sodium 1,537mg equivalent to 1500mg cefuroxime anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Hikma Farmaceutica (Portugal) Lda, Cruzamento de Vila Verde, Fervenca, Terrugem - Sintra, Portugal
Product: Cefuroxime 250mg
Active Ingredient(s): Cefuroxime sodium 256mg equivalent to 250mg cefuroxime anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Hikma Farmaceutica (Portugal) Lda, Cruzamento de Vila Verde, Fervenca, Terrugem - Sintra, Portugal
Product: Cefuroxime 750mg
Active Ingredient(s): Cefuroxime sodium 769mg equivalent to 750mg cefuroxime anhydrous
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Hikma Farmaceutica (Portugal) Lda, Cruzamento de Vila Verde, Fervenca, Terrugem - Sintra, Portugal
Product: Plan Safer
Active Ingredient(s): Nonoxinol 9 9%w/w
Dosage Form: Condom with spermicide
New Zealand Sponsor: Meridian Developments Limited
Manufacturer(s): Sagami Industries (Malaysia) Sdn. Berhad, Ipoh, Perak, Malaysia
Product: Zyrtec Decongestant
Active Ingredient(s): Cetirizine hydrochloride 5mg
Pseudoephedrine hydrochloride 120mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer(s): UCB Pharma, Limay, France
Product: Zyrtec Decongestant
Active Ingredient(s): Cetirizine hydrochloride 5mg
Pseudoephedrine hydrochloride 120mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer(s): Farchim S.A., Bulle, Switzerland
Dated this 4th day of April 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).