31 JULY NEW ZEALAND GAZETTE 2285

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Copegus
Active Ingredient: Ribavirin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada

Dated this 22nd day of July 2003.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Safety and Regulation, 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 an injection or eye preparation, to
any concentration of that medicine; and

(ii) if the medicine is not 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

Atazanavir
Aprepitant
Carbetocin
Fluorides; for internal use except in parenteral nutrition
replacement preparations or in medicines containing
2.2 milligrams or less per dose form of sodium fluoride;
for external use in medicines other than pastes, gels or
powders for cleaning the teeth containing more than
2.5% except when used in practice by a registered dental
therapist; except in medicines containing 15 milligrams
or less per litre or per kilogram
Haemophilus influenzae vaccine; except in oral vaccines for
the prophylaxis of bacterial complications of colds
Human protein C

Laronidase-rch
Lumiracoxib
Melagatran
Pneumococcal vaccine; except in oral vaccines for the
prophylaxis of bacterial complications of colds
Polyacrylamide; in injections or implantations for tissue
augmentation or cosmetic use
Polylactic acid; in injections or implantations for tissue
augmentation or cosmetic use
Ximelagatran

Schedule 2

Restricted Medicines

Fluorides; in pastes, gels or powders for cleaning the teeth
containing more than 0.1%
Haemophilus influenzae vaccine; in oral vaccines for the
prophylaxis of bacterial complications of colds
Pneumococcal vaccine; in oral vaccines for the prophylaxis
of bacterial complications of colds

Schedule 3

Pharmacy-only Medicines

Fluorides; for internal use in medicines containing 2.2
milligrams or less per dose form of sodium fluoride; for
external use in medicines other than pastes, gels or
powders for cleaning the teeth containing 2.5% or less;
except in oral hygiene products other than pastes, gels or
powders for cleaning the teeth containing 0.01% or less;
Hyoscyamus niger; for oral use in liquid form in medicines
containing 0.03% and 0.3 milligrams or less per dose
and not more than 1.2 milligrams per recommended
daily dose of total solanaceous alkaloids or in solid dose
form in medicines containing 0.3 milligrams or less
per dose unit and not more than 1.2 milligrams per
recommended daily dose except in packs containing
30 micrograms or less of total solanaceous alkaloids
*Nizatidine; in medicines which have received the consent
of the Minister or the director-general to their sale
as pharmacy-only medicines and which are sold in the
manufacturer’s original pack containing not more than
14 days supply

Medicines for General Sale

Please note that the following medicines are no longer
classified as prescription medicines, restricted medicines or
pharmacy-only medicines. As such, they are now available
for general sale.

Fluorides; in pastes, gels or powders for cleaning the
teeth containing 0.1% or less; in oral hygiene products
other than pastes, gels or powders for cleaning the
teeth containing 0.01% or less; in parenteral nutrition