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: Atehexal
Active Ingredient(s): Atenolol 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
Salutas Pharma GmbH, Barleben, Germany
Product: Atehexal
Active Ingredient(s): Atenolol 50
Dosage Form: Film coated tablet
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
Salutas Pharma GmbH, Barleben, Germany
Product: At-Eze
Active Ingredient(s): Oxymetazoline hydrochloride 0.25mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing, division of Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: At-Eze
Active Ingredient(s): Oxymetazoline hydrochloride 0.5mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing, division of Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: Clorotir
Active Ingredient(s): Cefaclor (monohydrate) 262.3mg equivalent to 250mg cefaclor
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Clorotir
Active Ingredient(s): Cefaclor (monohydrate) 524.7mg equivalent to 500mg cefaclor
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: DaktaGOLD
Active Ingredient(s): Ketoconazole 20mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Product: Relenza Rotadisk
Active Ingredient(s): Zanamivir 5mg
Dosage Form: Powder for inhalation
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Australia Limited, Boronia, Victoria, Australia
Glaxo Wellcome Production, Evreux, France
Product: SBPA Ranitidine 150
Active Ingredient(s): Ranitidine hydrochloride 167.5mg equivalent to 150mg ranitidine
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal Pradesh, India
Product: SBPA Ranitidine 300
Active Ingredient(s): Ranitidine hydrochloride 335mg equivalent to 300mg ranitidine
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal Pradesh, India
Dated this 7th day of March 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).