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: Cephazolin Sodium for Injection
Active Ingredient(s): Cephazolin sodium 1,048mg equivalent to 1g cephazolin
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limted
Manufacturer(s): Biopharma SrL, Santa Palomba, Rome, Italy
Mitim Srl, Brescia, Italy
Product: Cephazolin Sodium for Injection
Active Ingredient(s): Cephazolin sodium 524mg equivalent to 500mg cephazolin
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Biopharma SrL, Santa Palomba, Rome, Italy
Mitim Srl, Brescia, Italy
Product: Lemnis Fatty Cream HC
Active Ingredient(s): Hydrocortisone 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Yamanouchi Europe BV, Meppel, The Netherlands
Product: Losec MUPS
Active Ingredient(s): Omeprazole magnesium 10.3mg equivalent to 10mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Losec MUPS
Active Ingredient(s): Omeprazole magnesium 20.6mg equivalent to 20mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Losec MUPS
Active Ingredient(s): Omeprazole magnesium 41.3mg equivalent to 40mg omeprazole
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Naropin
Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 5.29mg/mL equiv to 5mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Dated this 7th day of February 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).