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: Auralgan Ear Drops
Active Ingredient(s): Benzocaine 14mg/mL
Phenazone 54mg/mL
Dosage Form: Ear drops
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): Interphil Laboratories Inc, Pittland, Cabuyao, Laguna, Philippines
Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia
Product: Buspirex
Active Ingredient(s): Buspirone hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Technilab Inc
Manufacturer(s): Technilab (Canada) Inc, Mirabel, Quebec, Canada
Product: Neurontin
Active Ingredient(s): Gabapentin 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Parke Davis (Div. Warner Lambert NZ Limited)
Manufacturer(s): Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Product: Neurontin
Active Ingredient(s): Gabapentin 800mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Parke Davis (Div. Warner Lambert NZ Limited)
Manufacturer(s): Warner-Lambert Inc, Vega Baja, Puerto Rico
Product: Roferon-A
Active Ingredient(s): Interferon alpha-2a 30MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Basle, Switzerland
Product: Tramal Retard
Active Ingredient(s): Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Product: Tramal Retard
Active Ingredient(s): Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Product Tramal Retard
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Grunenthal GmbH, Stolberg, Germany
Dated this 11th day of October 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).