7 JULY 2011

NEW ZEALAND GAZETTE, No. 96

2809

Product:

Sudafed PE Phenylephrine Sinus Day + Night Relief (Combination Product)

Day Tablet

Active Ingredients:

• Paracetamol 500mg
• Phenylephrine hydrochloride 5mg

Dosage Form:
Tablet

Night Tablet

Active Ingredients:

• Chlorphenamine maleate 2mg
• Paracetamol 500mg
• Phenylephrine hydrochloride 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited

Manufacturers:

• Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
• Janssen-Cilag, Val de Reuil, France

Product:

Varilrix Vaccine

Active Ingredient:
Varicella vaccine 2000PFU

Dosage Form:
Solution for injection

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 30th day of June 2011.

JOHN HOLMES, 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, Mark Jacobs, 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.

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 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

Amyl nitrite; except when sold to a person who holds a valid Controlled Substances Licence authorising them to possess cyanide

Benzocaine; except when specified elsewhere in this notice; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit

Calcipotriol; except in medicines containing not more than 50 micrograms per gram or per millilitre and when sold in a pack of not more than 30 grams or 30 millilitres by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor

Canakinumab

Certolizumab pegol

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

Clofarabine

Codeine; except when specified elsewhere in this notice

Corifollitropin alfa

Eltrombopag olamine

Famciclovir; except when specified elsewhere in this notice

Fampridine

Fexofenadine; except for oral use

Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 milligrams per litre or per kilogram except when supplied to a dental professional recognised by the Dental Council of New Zealand

Flurbiprofen; except in locally acting oromucosal preparations containing 10 milligrams or less per preparation