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-XR. Active Ingredient(s): Venlafaxine hydrochloride 169.7 mg equivalent to 150 mg venlafaxine. Dosage Form: Modified release capsule. NZ Sponsor: Wyeth (NZ) Limited. Manufacturer(s): Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico. Product: Efexor-XR. Active Ingredient(s): Venlafaxine hydrochloride 84.85 mg equivalent to 75 mg venlafaxine. Dosage Form: Modified release capsule. NZ Sponsor: Wyeth (NZ) Limited. Manufacturer(s): Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico. Product: Recombinate. Active Ingredient(s): Factor VIII (recombinant) 1000 IU. Dosage Form: Powder for injection. NZ Sponsor: Baxter Healthcare Limited. Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America. Baxter Healthcare Corporation, Los Angeles, United States of America. Product: Recombinate. Active Ingredient(s): Factor VIII (recombinant) 250 IU. Dosage Form: Powder for injection. NZ Sponsor: Baxter Healthcare Limited. Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America. Baxter Healthcare Corporation, Los Angeles, United States of America. Product: Recombinate. Active Ingredient(s): Factor VIII (recombinant) 500 IU. Dosage Form: Powder for injection. NZ Sponsor: Baxter Healthcare Limited. Manufacturer(s): Baxter Healthcare Corporation, Thousand Oaks, California, United States of America. Baxter Healthcare Corporation, Los Angeles, United States of America. Product: Risperdal. Active Ingredient(s): Risperidone 1 mg/mL. Dosage Form: Oral solution. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 1, Beerse, Belgium. Product: Risperdal. Active Ingredient(s): Risperidone 1 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 2 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 3 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 4 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 6 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Product: Risperdal. Active Ingredient(s): Risperidone 8 mg. Dosage Form: Film coated tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium. Janssen-Cilag SpA, Borgo San Michele, Latina, Italy. Dated this 1st day of December 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).