Provisional Consent to the Distribution of New Medicines

Notice Type: Departmental
Notice Title: Provisional Consent to the Distribution of New Medicines

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: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:	Metoprolol Succinate Extended Release Tablets Metoprolol succinate 23.75mg equivalent to metoprolol tartrate 25mg Modified release tablet AFT Pharmaceuticals Limited Actavis Laboratories FL Incorporated, Florida, United States
Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:	Metoprolol Succinate Extended Release Tablets Metoprolol succinate 47.5mg equivalent to metoprolol tartrate 50mg Modified release tablet AFT Pharmaceuticals Limited Actavis Laboratories FL Incorporated, Florida, United States
Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:	Metoprolol Succinate Extended Release Tablets Metoprolol succinate 95mg equivalent to metoprolol tartrate 100mg Modified release tablet AFT Pharmaceuticals Limited Actavis Laboratories FL Incorporated, Florida, United States
Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:	Metoprolol Succinate Extended Release Tablets Metoprolol succinate 190mg equivalent to metoprolol tartrate 200mg Modified release tablet AFT Pharmaceuticals Limited Actavis Laboratories FL Incorporated, Florida, United States

Note: Provisional consent is subject to the following restriction: The medicine may only be marketed or distributed when no other brands of metoprolol are available in the New Zealand market and to meet sole tender obligations.

Note: This renewed consent is valid for six months from the date of publication of this notice.

Dated this 28th day of June 2016.

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

Publication Date: 30 Jun 2016

Tags: Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number: 2016-go3777
Issue Number: 60

Title: View PDF
Description: Principal Edition, 30 June 2016
File Type and Size: PDF (22 KB)
Page Number 0

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