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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
12 Jul 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go3356
Title
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File Type and Size
PDF (36 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer: Amneal Pharmaceuticals of New York, LLC, New York, United States of America

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer: Amneal Pharmaceuticals of New York, LLC, New York, United States of America

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 20mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer: Amneal Pharmaceuticals of New York, LLC, New York, United States of America

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 12th day of July 2024.

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