368 NEW ZEALAND GAZETTE, No. 12 11 FEBRUARY 2010

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America

Note: This renewed consent is valid for two years from 23 March 2010.

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America

Note: This renewed consent is valid for two years from 23 March 2010.

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America

Note: This renewed consent is valid for two years from 23 March 2010.

Dated this 5th day of February 2010.

ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, 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, Mark Richards, Acting Deputy Director-General, Regulation and Governance Directorate, 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.

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

Schedule 1

Prescription Medicines

Chloramphenicol; except when sold in practice by a registered optometrist; except when specified elsewhere in this notice

Corifollitropin alfa

Famciclovir; except when specified elsewhere in this notice

Fexofenadine; except for oral use

Heparins; for internal use; except when present as an excipient

Human papillomavirus vaccine

Ibogaine

Japanese encephalitis vaccine

Lansoprazole; except when specified elsewhere in this notice

Loperamide; except when specified elsewhere in this notice

Noribogaine

Omeprazole; except when specified elsewhere in this notice

Pazopanib

Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this notice

Stramonium; except for oral use when specified elsewhere in this notice; except datura stramonium or datura tatula for smoking or burning