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: Alendrex
Active Ingredient: Alendronate sodium trihydrate 45.68mg equivalent to 35mg alendronate
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Alendrex
Active Ingredient: Alendronate sodium trihydrate 91.37mg equivalent to 70mg alendronate
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Zantac
Active Ingredient: Ranitidine hydrochloride 168mg equivalent to ranitidine 150mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
GlaxoSmithKline (Tianjin) Co Limited, TEDA, Tianjin, China
GlaxoSmithKline Australia Pty Limited, Boronia, Victoria, Australia
Dated this 14th day of July 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).