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: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.05mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.125mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Floair HFA Inhaler
Active Ingredient: Fluticasone propionate 0.25mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Meterol HFA Inhaler
Active Ingredient: 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 January 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).