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: Anoro Ellipta
Active Ingredients: Umeclidinium bromide 74.2mcg equivalent to Umeclidinium 62.5mcg
Vilanterol trifenatate 40mcg equivalent to Vilanterol 25mcg
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Ropivacaine Kabi
Active Ingredient: Ropivacaine hydrochloride 2mg/mL equivalent to Ropivacaine 1.77mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Norge AS, Halden, Norway
Product: Ropivacaine Kabi
Active Ingredient: Ropivacaine hydrochloride 5mg/mL equivalent to Ropivacaine 4.43mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Norge AS, Halden, Norway
Product: Ropivacaine Kabi
Active Ingredient: Ropivacaine hydrochloride 7.5mg/mL equivalent to Ropivacaine 6.64mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Norge AS, Halden, Norway
Product: Ropivacaine Kabi
Active Ingredient: Ropivacaine hydrochloride 10mg/mL equivalent to Ropivacaine 8.85mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Norge AS, Halden, Norway
Product: Sovaldi
Active Ingredient: Sofosbuvir 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturers: Gilead Sciences Limited, Cork, Ireland
Patheon Inc, Ontario, Canada
Dated this 14th day of March 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).