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 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: Forteo
Active Ingredient: Teriparatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly France SAS, Fegersheim, France
Product: Vaxigrip Junior
Active Ingredients: Influenza virus A/California/7/2009 (H1N1) - like strain 7.5µg/dose
Influenza virus A/Perth/16/2009 (H3N2) - like strain 7.5µg/dose
Influenza virus B/Brisbane/60/2008 - like strain 7.5µg/dose
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Pasteur SA, Val-De-Reuil Cedex, France
Sanofi Pasteur SA, Marcy L’Etoile, France
Product: Vaxigrip vaccine
Active Ingredients: Influenza virus A/California/7/2009 (H1N1) - like strain 15µg/dose
Influenza virus A/Perth/16/2009 (H3N2) - like strain 15µg/dose
Influenza virus B/Brisbane/60/2008 - like strain 15µg/dose
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi Pasteur SA, Val-De-Reuil Cedex, France
Product: Zeldox
Active Ingredient: Ziprasidone hydrochloride monohydrate 22.65mg equivalent to 20mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Product: Zeldox
Active Ingredient: Ziprasidone hydrochloride monohydrate 45.3mg equivalent to 40mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Product: Zeldox
Active Ingredient: Ziprasidone hydrochloride monohydrate 67.95mg equivalent to 60mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Product: Zeldox
Active Ingredient: Ziprasidone hydrochloride monohydrate 90.6mg equivalent to 80mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Product: Zeldox
Active Ingredient: Ziprasidone hydrochloride monohydrate 113.25mg equivalent to 100mg ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Product: Zeldox (Titration pack)
Active Ingredient: Ziprasidone hydrochloride monohydrate 45.3mg equivalent to 40mg Ziprasidone
Dosage Form: Capsule
Active Ingredient: Ziprasidone hydrochloride monohydrate 67.95mg equivalent to 60mg Ziprasidone
Dosage Form: Capsule
Active Ingredient: Ziprasidone hydrochloride monohydrate 90.6mg equivalent to 80mg Ziprasidone
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Australia Pty Limited, New South Wales, Australia
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany
Dated this 15th day of January 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).