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: NovoSeven RT
Active Ingredient: Factor VIIa, recombinant human 8mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: RexAir HFA Inhaler
Active Ingredients: Fluticasone propionate 0.05mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: RexAir HFA Inhaler
Active Ingredients: Fluticasone propionate 0.125mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: RexAir HFA Inhaler
Active Ingredients: Fluticasone propionate 0.25mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Dated this 10th day of May 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).