Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: AdiraMedica Docusate Sodium & Senna Tablets
Active Ingredients: Docusate sodium 50mg
Sennoside A+B calcium 40mg equivalent to 8mg senna
Dosage Form: Film coated tablet
New Zealand Sponsor: AdiraMedica Pty Limited
Manufacturer: Sunglow Lifescience Private Limited, Uthiramerur Taluk, India
   
Product: Deventer
Active Ingredients: Fluticasone propionate 15mg equivalent to 125mcg/dose
Salmeterol xinafoate 4.356mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Deventer
Active Ingredients: Fluticasone propionate 30mg equivalent to 250mcg/dose
Salmeterol xinafoate 4.356mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Fluticasone + Salmeterol
Active Ingredients: Fluticasone propionate 20.88mg equivalent to 125mcg/dose
Salmeterol xinafoate 6.07mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Verna, India
   
Product: Fluticasone + Salmeterol
Active Ingredients: Fluticasone propionate 41.75mg equivalent to 250mcg/dose
Salmeterol xinafoate 6.07mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Verna, India
   
Product: Fluticasone + Salmeterol Cipla
Active Ingredients: Fluticasone propionate 20.88mg equivalent to 125mcg/dose
Salmeterol xinafoate 6.07mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Verna, India
   
Product: Fluticasone + Salmeterol Cipla
Active Ingredients: Fluticasone propionate 41.75mg equivalent to 250mcg/dose
Salmeterol xinafoate 6.07mg equivalent to salmeterol 25mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Verna, India
   
Product: Germicyde
Active Ingredient: Hydrogen peroxide 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: Bioglan AB, Malmo, Sweden
   
Product: Zalve
Active Ingredient: Hydrogen peroxide 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: Bioglan AB, Malmo, Sweden


Dated this 29th day of August 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).