NEW ZEALAND GAZETTE, No. 43

19 APRIL 2007

Medicines Act 1981

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 set out in the Schedule hereto:

Schedule

Product:
Humira Pen

Active Ingredient:
Adalimumab 50mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturers:
Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product:
Otrivin Adult Nasal Drops

Active Ingredient:
Xylometazoline hydrochloride 0.1%w/v

Dosage Form:
Nasal drops

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty. Limited

Manufacturer:
Novartis Consumer Health SA, Prangins, Nyon, Switzerland

Product:
Otrivin Adult Nasal Spray

Active Ingredient:
Xylometazoline hydrochloride 0.1%w/v

Dosage Form:
Nasal spray solution

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty. Limited

Manufacturer:
Novartis Consumer Health SA, Prangins, Nyon, Switzerland

Product:
Otrivin Junior Nasal drops

Active Ingredient:
Xylometazoline hydrochloride 0.05%w/v

Dosage Form:
Nasal drops

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty. Limited

Manufacturer:
Novartis Consumer Health SA, Prangins, Nyon, Switzerland

Product:
Otrivin Junior Nasal Spray

Active Ingredient:
Xylometazoline hydrochloride 0.05%w/v

Dosage Form:
Nasal spray solution

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty. Limited

Manufacturer:
Novartis Consumer Health SA, Prangins, Nyon, Switzerland

Product:
Ventavis

Active Ingredient:
Iloprost 20µg

Dosage Form:
Solution for inhalation

New Zealand Sponsor:
Schering (NZ) Limited

Manufacturer:
Berlimed SA, Pologono Industrial Santa Rosa, Henares, Madrid, Spain

Dated this 12th day of April 2007.

MARK JACOBS, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go2503

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Don Matheson, Deputy Director-General, Public Health 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 or the concentration of the total active principles 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 the free acid, base, alcohol or element unless specifically stated otherwise.