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: MMR II Vaccine
Active Ingredient(s): Measles vaccine (live attenuated) 1,000TCID50
Mumps vaccine 5,000TCID50
Rubella vaccine 1,000TCID50
Dosage Form: Suspension for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Puregon
Active Ingredient(s): Follitropin beta 100IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 150IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 200IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 225IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 250IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 833IU/mL equivalent to 300IU in 0.36mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Puregon
Active Ingredient(s): Follitropin beta 50IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 833IU/mL equivalent to 600IU in 0.72mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Puregon
Active Ingredient(s): Follitropin beta 75IU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): NV Organon, Oss, The Netherlands
Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Product: Puregon
Active Ingredient(s): Follitropin beta 100IU
Dosage Form: "lyosphere" Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Organon International BV, Oss, The Netherlands
Product: Puregon
Active Ingredient(s): Follitropin beta 150IU
Dosage Form: "lyosphere" Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Organon International BV, Oss, The Netherlands
Product: Puregon
Active Ingredient(s): Follitropin beta 50IU
Dosage Form: "lyosphere" Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Organon International BV, Oss, The Netherlands
Product: Puregon
Active Ingredient(s): Follitropin beta 75IU
Dosage Form: "cake" Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Organon International BV, Oss, The Netherlands
Dated this 6th day of June 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).