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: Arrow – Cetirizine
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany
Product: Fluad
Active Ingredients: Influenza virus A/Wellington/I/2004(H3N2)-like strain 15µg/dose
Influenza virus B/Shanghai/361/2002-like strain 15µg/dose
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1-like strain 15µg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Medconsult Services Limited
Manufacturer: Novartis Vaccines and Diagnostics S.r.l, Localita Bellaria, Rosia, Italy
Product: Olanzapine – Rex
Active Ingredient: Olanzapine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, District – Pune, Maharashtra State, India
Product: Olanzapine – Rex
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, District – Pune, Maharashtra State, India
Product: Olanzapine – Rex
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, District – Pune, Maharashtra State, India
Product: Olanzapine – Rex
Active Ingredient: Olanzapine 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Manufacturing Division, District – Pune, Maharashtra State, India
Product: Univent 500mcg/2mL
Active Ingredient: Ipratropium bromide monohydrate 0.25mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Verna Industrial Area, Salcette, Goa, India
Dated this 29th day of March 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).