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
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2% Xylocaine DENTAL with Adrenaline 1:80,000
Adrenaline acid tartrate 0.0227mg equivalent to 12.5mcg adrenaline
Lidocaine hydrochloride monohydrate 21.3mg
equivalent to 20mg Lignocaine hydrochloride anhydrous
Suspension for injection
Dentsply (NZ) Limited
Pierrel S.p.A., Capua, Italy
Laboratorios INIBSA, S.A., Barcelona, Spain
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Product:
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Relistor
Methylnaltrexone bromide 12mg/0.6mL
Solution for injection
Link Pharmaceuticals Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product:
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Xtandi
Enzalutamide 40mg
Soft gelatin capsule
Seqirus (NZ) Limited
Catalent Pharma Solutions LLC, Florida, United States of America
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Dated this 25th day of August 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz