10 APRIL 2008

NEW ZEALAND GAZETTE, No. 71

1973

Schedule

Product: Norpress

Active Ingredient: Nortriptyline hydrochloride 11.385mg equivalent to 10mg Nortriptyline

Dosage Form: Tablet

New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)

Manufacturers: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Pacific Pharmaceuticals Limited (part of Mylan), Auckland, New Zealand

Product: Norpress

Active Ingredient: Nortriptyline hydrochloride 28.463mg equivalent to 25mg Nortriptyline

Dosage Form: Tablet

New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)

Manufacturers: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Pacific Pharmaceuticals Limited (part of Mylan), Auckland, New Zealand

Dated this 7th day of April 2008.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of a New Medicine

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

Schedule

Product: Exjade

Active Ingredient: Deferasirox 125mg

Dosage Form: Dispersible tablet

New Zealand Sponsor: Novartis New Zealand Limited

Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This consent is valid for two years from 11 May 2008.

Product: Exjade

Active Ingredient: Deferasirox 250mg

Dosage Form: Dispersible tablet

New Zealand Sponsor: Novartis New Zealand Limited

Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This consent is valid for two years from 11 May 2008.

Product: Exjade

Active Ingredient: Deferasirox 500mg

Dosage Form: Dispersible tablet

New Zealand Sponsor: Novartis New Zealand Limited

Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This consent is valid for two years from 11 May 2008.

Dated this 7th day of April 2008.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding Directorate, acting under delegated authority, hereby declare the following:

1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(c) preparations or extracts of biological materials listed in the notice.

(d) salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using