Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Efexor
Active Ingredient: Venlafaxine hydrochloride 42.4mg equivalent to 37.5mg venlafaxine base
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: John Wyeth and Brother Limited, Havant, Hampshire, United Kingdom
Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia
Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor
Active Ingredient: Venlafaxine hydrochloride 56.5mg equivalent to 50mg venlafaxine base
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: John Wyeth and Brother Limited, Havant, Hampshire, United Kingdom
Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia
Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor
Active Ingredient: Venlafaxine hydrochloride 84.8mg equivalent to 75mg venlafaxine base
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: John Wyeth and Brother Limited, Havant, Hampshire, United Kingdom
Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia
Wyeth Medica Ireland, Little Connell, Newbridge, County Kildare, Ireland
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 169.7mg equivalent to 150mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 84.85mg equivalent to 75mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Solution for injection (0.6mL pre-filled syringe)
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: Solution for injection (0.3mL pre-filled syringe)
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Dated this 3rd day of April 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).