Notice Type
Departmental
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: Cefuroxime for injection. Active Ingredient(s): Cefuroxime sodium 1.578 g equivalent to 1.5 g cefuroxime. Dosage Form: Powder for injection. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): ACS Dobfar SpA, Tribiano, Milan, Italy. Eli Lilly Italia SpA, Sesto Fiorentino, Florence, Italy. Product: Cefuroxime for Injection. Active Ingredient(s): Cefuroxime sodium 263 mg equivalent 250 mg cefuroxime. Dosage Form: Powder for injection. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): ACS Dobfar SpA, Tribiano, Milan, Italy. Eli Lilly Italia SpA, Sesto Fiorentino, Florence, Italy. Product: Cefuroxime for Injection. Active Ingredient(s): Cefuroxime sodium 789 mg equivalent to 750 mg cefuroxime. Dosage Form: Powder for injection. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): ACS Dobfar SpA, Tribiano, Milan, Italy. Eli Lilly Italia SpA, Sesto Fiorentino, Florence, Italy. Product: Epaxal Berna. Active Ingredient(s): Hepatitis A vaccine 500RIA U. Dosage Form: Suspension for injection. NZ Sponsor: Pharmabroker Sales Limited. Manufacturer(s): Swiss Serum and Vaccine Institute Berne, Berne, Switzerland. Product: Pinetarsol Bath Oil. Active Ingredient(s): Pine tar 2.5% w/w. Dosage Form: Bath oil. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia. Product: Synermox Syrup 125. Active Ingredient(s): Amoxycillin (trihydrate) 29.5 mg/mL equivalent to 25 mg/mL amoxycillin. Potassium clavulanate 15.55 mg/mL equivalent to 6.25 mg/mL clavulanic acid. Dosage Form: Powder for oral suspension. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India. Product: Synermox Syrup 250. Active Ingredient(s): Amoxycillin (trihydrate) 59 mg/mL equivalent to 50 mg/mL amoxycillin. Potassium clavulanate 31.1 mg/mL equivalent to 12.5 mg/mL clavulanic acid. Dosage Form: Powder for oral suspension. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India. Dated this 4th day of November 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
11 Nov 1999

Notice Number

1999-go8206

Page Number

3988