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: Avandamet
Active Ingredients: Metformin hydrochloride 1,000mg
Rosiglitazone maleate 2.65mg equivalent to rosiglitazone 2mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Avandamet
Active Ingredients: Metformin hydrochloride 1,000mg
Rosiglitazone maleate 5.3mg equivalent to rosiglitazone 4mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Pegasys RBV (Combination Product)
Active Ingredient: Peginterferon alfa-2a 270µg/mL
Dosage Form: Solution for injection
Manufacturer: F.Hoffman – La Roche AG, Basel, Switzerland
Active Ingredient: Ribavirin 200mg
Dosage Form: Film-coated tablet
Manufacturers: Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
New Zealand Sponsor: Roche Products (New Zealand) Limited
Product: Pegasys RBV (Combination Product)
Active Ingredient: Peginterferon alfa-2a 360µg/mL
Dosage Form: Solution for injection
Manufacturer: F.Hoffman – La Roche AG, Basel, Switzerland
Active Ingredient: Ribavirin 200mg
Dosage Form: Film-coated tablet
Manufacturers: Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
New Zealand Sponsor: Roche Products (New Zealand) Limited
Product: Roferon-A RBV (Combination Product)
Active Ingredient: Interferon alfa-2a 30MIU/mL
Dosage Form: Solution for injection
Manufacturers: Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
Weimer Pharma GmbH, Rastatt, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Film-coated tablet
Manufacturers: Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
Weimer Pharma GmbH, Rastatt, Germany
New Zealand Sponsor: Roche Products (New Zealand) Limited
Product: Roferon-A RBV (Combination Product)
Active Ingredient: Interferon alfa-2a 6MIU/mL
Dosage Form: Solution for injection
Manufacturers: F.Hoffmann – La Roche Limited, Basel, Switzerland
Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
Active Ingredient: Ribavirin 200mg
Dosage Form: Film-coated tablet
Manufacturers: F.Hoffmann – La Roche Limited, Basel, Switzerland
Hoffmann – La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
New Zealand Sponsor: Roche Products (New Zealand) Limited
Product: Sensipar
Active Ingredient: Cinacalcet hydrochloride 33mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Amgen Australia Pty Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Product: Sensipar
Active Ingredient: Cinacalcet hydrochloride 66mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Amgen Australia Pty Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Product: Sensipar
Active Ingredient: Cinacalcet hydrochloride 99mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Amgen Australia Pty Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Dated this 26th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).