Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, acting under delegated authority,
hereby declare that the medicine listed in Schedule 3 to this notice is classified as a pharmacy-only medicine.
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 3
Pharmacy-only Medicines
Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis in adults and children
12 years of age and over when in capsules containing
60 milligrams or less of fexofenadine hydrochloride
or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 10 dosage units or less and not more than 5 days’ supply
Medicines for General Sale
Please note that the following medicine is now available for general sale.
Fexofenadine; for the treatment of seasonal allergic
rhinitis in adults and children 12 years of age and over when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 10 dosage units or less and not more than 5 days’ supply
Dated this 19th day of March 2012.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.