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: Amcal Paracetamol (Orange flavour)
Active Ingredient: Paracetamol 4.167%w/w
Dosage Form: Oral suspension
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland
Product: Amcal Paracetamol (Strawberry flavour)
Active Ingredient: Paracetamol 2.4%w/v
Dosage Form: Oral suspension
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland
Product: Bayer Aspirin, Extra Strength
Active Ingredient: Aspirin 500mg
Dosage Form: Tablet
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturers: Bayer Bitterfeld GmbH, Greppin, Germany
P T Bayer Indonesia Tbk, Cibubur, Jakarta, Indonesia
Product: Febridol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Cipla Limited, Kurkumbh Village, Taluka - Daund, District - Pune (Maharashtra), India
Product: Paracetamol Tablets (Pams)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India
Cipla Limited, Kurkumbh Village, Taluka - Daund, District - Pune (Maharashtra), India
Product: Sudocrem
Active Ingredient: Zinc oxide 15.25%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Counterpoint Marketing Services (NZ) Pty Limited
Manufacturer: Tosara Products Limited, Baldoyle, Dublin, Ireland
Dated this 23rd day of August 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).