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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Chloramphenicol LINK
Chloramphenicol sodium succinate 1.4g equivalent to chloramphenicol 1g
Powder for injection
Link Pharmaceuticals Limited
VUAB Pharma A.S, Roztoky, Czech Republic

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Sirdupla MDI
Fluticasone propionate 0.125mg equivalent to 125mcg/dose
Salmeterol xinafoate 0.0363mg equivalent to salmeterol 25mcg/dose
Aerosol inhaler, metered dose
Mylan New Zealand Limited
3M Health Care (UK) Limited, Loughborough, United Kingdom

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Sirdupla MDI
Fluticasone propionate 0.25mg equivalent to 250mcg/dose
Salmeterol xinafoate 0.0363mg equivalent to salmeterol 25mcg/dose
Aerosol inhaler, metered dose
Mylan New Zealand Limited
3M Health Care (UK) Limited, Loughborough, United Kingdom

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tenofovir Disoproxil Emtricitabine Efavirenz Mylan
Efavirenz 600mg
Emtricitabine 200mg
Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Pithampur, India

Dated this 19th day of July 2018.

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