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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: Alcoholic Povidone-Iodine
Active Ingredient: Povidone-iodine 100mg/mL equivalent to iodine 1%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer (Perth) Pty Limited, Perth, Australia
   
Product: Danica 35 ED
Active Ingredients: Cyproterone acetate 2mg
Ethinylestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Ahmedabad, India
   
Product: Ganciclovir SXP
Active Ingredient: Ganciclovir sodium 543mg equivalent to ganciclovir 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Southern Cross Pharma NZ Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
   
Product: Half Strength Povidone-Iodine
Active Ingredient: Povidone-iodine 50mg/mL equivalent to iodine 0.5%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer (Perth) Pty Limited, Perth, Australia


Dated this 26th day of February 2021.

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