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: Naropin
Active Ingredient: Ropivacaine hydrochloride (monohydrate) 2.12mg/mL equivalent to 2mg/ml Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Limited, North Ryde, New South Wales, Australia
NPBI BV, Runde, Emmer-Compascuum, The Netherlands
Product: Risperdal
Active Ingredient: Risperidone 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Risperdal
Active Ingredient: Risperidone 0.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Topamax Sprinkle
Active Ingredient: Topiramate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical ( a division of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 25mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical ( a division of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 50mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical ( a division. of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Ultiva
Active Ingredient: Remifentanil hydrochloride 1.1mg equivalent to 1mg remifentanil
Dosage Form: Powder for injection
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer: Pharmacia NV/SA, Puurs, Belgium
Product: Ultiva
Active Ingredient: Remifentanil hydrochloride 2.2mg equivalent to 2mg remifentanil
Dosage Form: Powder for injection
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer: Pharmacia NV/SA, Puurs, Belgium
Product: Ultiva
Active Ingredient: Remifentanil hydrochloride 5.5mg equivalent to 5mg remifentanil
Dosage Form: Powder for injection
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer: Pharmacia NV/SA, Puurs, Belgium
Dated this 6th day of March 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on 20 February 1997).