NEW ZEALAND GAZETTE, No. 118

4 AUGUST 2011

Product:
Actilyse
Active Ingredient:
Alteplase 50mg
Dosage Form:
Powder for injection
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product:
Mabthera
Active Ingredient:
Rituximab 10mg/mL
Dosage Form:
Concentrate for infusion
New Zealand Sponsor:
Roche Products (NZ) Limited
Manufacturers:
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, California, United States of America

Product:
Telfast
Active Ingredient:
Fexofenadine hydrochloride 30mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
sanofi-aventis new zealand limited
Manufacturer:
sanofi-aventis us llc, Missouri, United States of America

Dated this 28th day of July 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (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, Stewart Jessamine, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, 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.

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 the free acid, base, alcohol or element unless specifically stated otherwise.

Schedule 1

Prescription Medicines
Afamelanotide
Asenapine
Belimumab
Degarelix
Denosumab
Dronedarone
Eculizumab
Fingolimod
Guaiphenesin; for oral use in medicines containing more than 2% or 200 milligrams per dose form except when specified elsewhere in this schedule; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing not more than 10 days’ supply approved by the Minister or the Director-General for distribution as a general sale medicine
Icatibant
Indacaterol
Linagliptin
Nitisinone
Nomegestrol
Plerixafor
Prucalopride
Rupatadine
Sapropterin
Tafluprost
Telaprevir
Ticagrelor
Vorinostat

Schedule 2

Restricted Medicines
Guaiphenesin; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack containing more than 10 days’ supply but not more than 30 days’ supply approved by the Minister or the Director-General for distribution as a restricted medicine

Medicines for General Sale

Please note that the following medicines are now available for general sale.

C1 esterase inhibitors
Guaiphenesin; for oral use in medicines containing 2% or less or 200 milligrams or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams sold in a pack