β¨ Medicine Distribution Consents
NEW ZEALAND GAZETTE, No. 77 β 1 SEPTEMBER 2016
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 10mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 15mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 20mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 30mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 40mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Oxycodone Modified Release Tablets
Oxycodone hydrochloride 80mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
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).
2016-go4993
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 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
Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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
45
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare25 August 2016
Medicines, Distribution, Consent, Pharmaceuticals, Oxycodone, Modified Release Tablets, Mylan
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Distribution, Consent, Pharmaceuticals, Xylocaine, Adrenaline, Lidocaine, Dentsply
NZ Gazette 2016, No 77