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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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Pitressin
Argipressin 20 pressor units/mL
Solution for injection
Link Pharmaceuticals Limited
Farmak JSC, Kyiv, Ukraine
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Suboxone 2/0.5
Buprenorphine hydrochloride 2.16mg equivalent to buprenorphine 2mg
Naloxone hydrochloride dihydrate 0.61mg equivalent to naloxone 0.5mg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Suboxone 8/2
Buprenorphine hydrochloride 8.64mg equivalent to buprenorphine 8mg
Naloxone hydrochloride dihydrate 2.44mg equivalent to naloxone 2mg
Sublingual tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Temgesic
Buprenorphine hydrochloride 0.324mg/mL equivalent to buprenorphine 0.3mg/mL
Solution for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
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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).
Gazette.govt.nz