1997 No. 1830
MEDICINES

The Prescription Only Medicines (Human Use) Order 1997

Made
Laid before Parliament
Coming into force
The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred on them by sections 58(1), (4) and (5), 59(1) and 129(4) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to sections 58(6) and 129(7) of that Act, hereby make the following Order:

Citation, commencement and interpretation1.

(1)

This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

(2)

In this Order, unless the context otherwise requires–

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“inhaler” does not include an aerosol;

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“maximum strength” means–

(a)

the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

(b)

the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

  1. (i)

    weight in weight,

  2. (ii)

    weight in volume,

  3. (iii)

    volume in weight, or

  4. (iv)

    volume in volume,

and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

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F8(2A)

In this Order, unless the context otherwise requires, any expression defined by any provision of the Human Medicines Regulations 2012 has the same meaning as it has for the purposes of those Regulations.

(3)

For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

(4)

In this Order, unless the context otherwise requires, a reference–

(a)

to a numbered section is to the section of the Act which bears that number,

(b)

to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

(c)

in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

(d)

in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

(5)

In F9Schedules 1 and 2

(a)

entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b)

the following abbreviations are used:

  • “g” for gram,

  • “iu” for international unit of activity,

  • “mcg” for microgram,

  • “mg” for milligram,

  • “ml” for millilitre.

F10(6)

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F10(7)

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F10(8)

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F10(9)

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Appropriate practitionersF112.

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Medicinal products on prescription onlyF113.

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Prescribing and administration by nurse independent prescribersF113A.

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Prescribing and administration by supplementary prescribersF113B.

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Exemptions from conditions in respect of the cases or circumstances in which a supplementary prescriber may administer a medicinal productF113C.

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Duration of special provisions in relation to new medicinal productsF114.

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Exempt medicinal products5.

(1)

F12A medicinal product that is not the subject of a marketing authorisation is a prescription only medicine for the purposes of the Human Medicines Regulations 2012 if it, or a substance in it, is listed in column 1 of Schedule 1, unless there

(a)

is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and that condition is satisfied in accordance with the following provisions of this article; or

(b)

there is more than one such condition which applies where that substance is used in that product and each of those conditions is so satisfied.

F13(1A)

In paragraph (1) “marketing authorisation” means—

(a)

in relation to medicinal products for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK);

(b)

in relation to medicinal products for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), an EU marketing authorisation or a parallel import licence.

(2)

Where a maximum strength is specified in column 2 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where the maximum strength of that substance in that medicinal product, or where specified in that column the maximum strength of a medicinal product which contains that substance, does not exceed that specified maximum or, where the medicinal product consists of more than one of the substances sodium fluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where the maximum strength of that combination of substances in a product does not exceed the equivalent of 0.15 per cent of fluorine.

(3)

Where a route of administration is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for administration only by that route.

(4)

Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied only for use–

(a)

where a purpose for which it may be used is so specified, for that purpose;

(b)

where the class of persons in whom it may be used is so specified, in persons of that class F14,

provided that, where the entry in column 3 contains a condition to the effect that the product is to be wholly or mainly for use in a specified class of persons, the product satisfies that condition where it is sold or supplied wholly or mainly for use in persons of that class.

(5)

Where a pharmaceutical form is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied in that pharmaceutical form.

(6)

Where a maximum dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum dose which does not exceed that specified maximum dose.

(7)

Subject to paragraph (8), where a maximum daily dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum daily dose which does not exceed that specified maximum daily dose.

(8)

A medicinal product which contains more than one of the substances–

  • Atropine

  • Atropine Methobromide

  • Atropine Methonitrate

  • Atropine Oxide Hydrochloride

  • Atropine Sulphate

  • Hyoscine

  • Hyoscine Butylbromide

  • Hyoscine Hydrobromide

  • Hyoscine Methobromide

  • Hyoscine Methonitrate

  • Hyoscyamine

  • Hyoscyamine Hydrobromide

  • Hyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which does not exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramonium or other solanaceous plant which are contained in that medicinal product.

(9)

Where a maximum period of use or a maximum frequency of use is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use for a maximum period or frequency, as the case may be, which does not exceed the maximum period of use or the maximum frequency of use which is so specified.

(10)

Where a maximum quantity is specified in column 5 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it, or where so specified in that column, the medicinal product which contains that substance is sold or supplied in a quantity which does not exceed that specified maximum quantity.

(11)

In paragraphs (2) to (7) and (9) and (10) a reference to a numbered column is a reference to the column bearing that number in Schedule 1.

Exemption for products consisting of or containing aloxiprin, aspirin or paracetamolF155A.

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Exemption for products consisting of or containing pseudoephedrine salts or ephedrine base or saltsF155B.

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Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicinesF156.

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Exemption for parenteral administration in an emergency to human beings of certain prescription only medicinesF157.

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Exemptions for administration of smallpox vaccineF157A.

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Exemption for administration by operatorsF117B.

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Exemptions for emergency sale or supplyF158.

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Exemption for non-parenteral administration to human beingsF159.

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Exemption for medicinal products at high dilutions10.

F16(1)

F17A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is a medicinal product which is not for parenteral administration and which consists of or contains, any of the substances listed in column 1 of Schedule 1 F18or in Schedule 2, only one or more unit preparation of such substances, if–

(a)

each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

(b)

each such unit preparation has been diluted to at least one part in a million million (6c).

F19(2)

F17A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is a medicinal product which is not for parenteral administration and which consists of or contains solely one or more unit preparations of the following substances—

  • Aconite

  • Arsenic Trioxide

  • Belladonna Herb

  • Ignatia Bean

  • Nux Vomica Seed,

if each such unit preparation has been diluted to at least one part in a million (6x)

Exemptions for certain personsF2011.

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Exemption for sale or supply in hospitalsF2012.

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Exemptions for the supply and administration of prescription only medicines by national health service bodiesF2012A.

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Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist doctors or dentists in providing national health servicesF2012B.

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Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group DirectionF2012C.

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Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agenciesF2012D.

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Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forcesF2012E.

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Exemption for the supply of prescription only medicines in the event or anticipation of pandemic diseaseF2012F.

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Exemption in cases involving another’s defaultF2013.

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Exemptions relating to prescriptions given by certain health professionals F2013A.

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Exemption in the case of a forged prescriptionF2014.

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PrescriptionsF2015.

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RevocationsF2016.

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Signed by authority of the Secretary of State for Health

Baroness Jay
Minister of State,
Department of Health
Win Griffiths
Parliamentary Under Secretary of State, Welsh Office
Sam Galbraith
Parliamentary Under Secretary of State, The Scottish Office
Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd July 1997.

D. C. Gowdy
Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.

P. Small
Permanent Secretary

SCHEDULE 1SUBSTANCES WHICH IF INCLUDED IN MEDICINAL PRODUCTS MAKE THOSE PRODUCTS PRESCRIPTION ONLY MEDICINES AND EXEMPTIONS FROM RESTRICTIONS ON THE SALE AND SUPPLY OF PRESCRIPTION ONLY MEDICINES

Articles 3(a), 5(1) and 10

Exemptions from the restrictions on the sale and supply of prescription only medicines

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Maximum strength

Route of administration, use or pharmaceutical form

Treatment limitations

Maximum quantity

F21Acamprosate

Acarbose

Acebutolol Hydrochloride

F21Aceclofenac

Acemetacin

Acetarsol

Acetazolamide

Acetazolamide Sodium

Acetohexamide

Acetylcholine Chloride

0.2 per cent

External

Acetylcysteine

Acipimox

Aciclovir

5.0 per cent

External

Container or package containing not more than 2g of medicinal product

For treatment of herpes simplex virus infections of the lips and face (Herpes labialis)

Acitretin

Aclarubicin Hydrochloride

Aconite

1.3 per cent

External

Acrivastine

24 mg (MDD)

Container or package containing not more than 240mg of Acrivastine

Acrosoxacin

Actinomycin C

Actinomycin D

F22Adapalene

Adenosine

Adrenaline

(1) By inhaler

(2) External F23(except ophthalmic)

Adrenaline Acid Tartrate

(1) By inhaler

(2) External

Adrenaline Hydrochloride

(1) By inhaler

(2) External

Adrenocortical Extract

Albendazole

Alclofenac

Alclometasone Dipropionate

Alcuronium Chloride

Aldesleukin

Aldosterone

F21Alendronate Sodium

Alfacalcidol

Alfuzosin Hydrochloride

Allergen Extracts

Allopurinol

Allyloestrenol

F24Aloxiprin

(1) 620 mg

(1) Non-effervescent tablets and capsules

(1) The quantity sold or supplied in one container or package shall not exceed 32

The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

(2) All preparations other than non-effervescent tablets or capsules

Alphadolone Acetate

Alphaxalone

Alprenolol

Alprenolol Hydrochloride

Alprostadil

Alseroxylon

F22Altretamine

Amantadine Hydrochloride

Ambenonium Chloride

Ambutonium Bromide

Amcinonide

Ametazole Hydrochloride

Amethocaine

Non-ophthalmic use

Amethocaine Gentisate

Non-ophthalmic use

Amethocaine Hydrochloride

Non-ophthalmic use

Amikacin Sulphate

Amiloride Hydrochloride

Aminocaproic Acid

Aminoglutethimide

Aminopterin Sodium

Amiodarone Hydrochloride

Amiphenazole Hydrochloride

F25Amisulpride

Amitriptyline

Amitriptyline Embonate

Amitriptyline Hydrochloride

Amlodipine Besylate

Ammonium Bromide

Amodiaquine Hydrochloride

Amorolfine Hydrochloride

Amoxapine

Amoxycillin

Amoxycillin Sodium

Amoxycillin Trihydrate

Amphomycin Calcium

Amphotericin

Ampicillin

Ampicillin Sodium

Ampicillin Trihydrate

Amsacrine

Amygdalin

Amyl Nitrite

Amylocaine Hydrochloride

Non-ophthalmic use

F21Anastrozole

Ancrod

Androsterone

Angiotensin Amide

Anistreplase

Anterior Pituitary Extract

Antimony Barium Tartrate

Antimony Dimercaptosuccinate

Antimony Lithium Thiomalate

Antimony Pentasulphide

Antimony Potassium Tartrate

Antimony Sodium Tartrate

Antimony Sodium Thioglycollate

Antimony Sulphate

Antimony Trichloride

Antimony Trioxide

Antimony Trisulphide

Apiol

Apomorphine

Apomorphine Hydrochloride

F22Apraclonidine Hydrochloride

Aprotinin

Arecoline Hydrobromide

Argipressin

Aristolochia

Aristolochia Clematitis

Aristolochia Contorta

Aristolochia Debelis

Aristolochia Fang-chi

Aristolochia Manshuriensis

Aristolochia Serpentaria

Arsenic

Arsenic Triiodide

Arsenic Trioxide

Arsphenamine

F26Aspirin

F27(1)

75mg

F27(1)

Non-effervescent tablets and capsules

F27(1)

The quantity sold or supplied in one container or package shall not exceed 100

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

F28F29(2)

500 mg

F29(2)

Non-effervescent tablets and capsules

F29(2)

The quantity sold or supplied in one container or package shall not exceed 32

F29(3)

All preparations other than non-effervescent tablets or capsules

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Astemizole

F30. . .

F30. . .

F30. . .

F30. . .

F30. . .

Atenolol

Atracurium Besylate

Atropine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External (except ophthalmic)

Atropine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

(2) External (except ophthalmic)

Atropine Methonitrate

Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg (MD)

1.3mg (MDD)

Atropine Oxide Hydrochloride

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD) 3

(2) External (except ophthalmic)

Atropine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg (MD)

1.2mg (MDD)

(2) External (except ophthalmic)

Auranofin

Azapropazone

Azathioprine

Azathioprine Sodium

Azelaic Acid

Azelastine Hydrochloride

For nasal administration

140mcg per nostril (MD)

Container or package containing not more than 5,040mcg of Azelastine Hydrochloride

For the treatment of seasonal allergic rhinitis F31or perennial allergic rhinitis

280mcg per nostril (MDD)

For use in adults and children not less than F325 years

As a non-aerosol, aqueous form

Azidocillin Potassium

Azithromycin

Azlocillin Sodium

Aztreonam

Bacampicillin Hydrochloride

Bacitracin

Bacitracin Methylene Disalicylate

Bacitracin Zinc

Baclofen

F25Balsalazide Sodium

Bambuterol Hydrochloride

Barium Carbonate

Barium Chloride

Barium Sulphide

Beclamide

Beclomethasone

Beclomethasone Dipropionate

For nasal administration (non-aerosol)

100mcg per nostril (MD)

Container or package containing not more than F3320,000 mcg of Beclomethasone Dipropionate

For the prevention and treatment of allergic rhinitis

200 mcg per nostril (MDD)

F34For a maximum period of 3 months

F35For use in persons aged 18 years and over

Belladonna Herb

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Belladonna Root

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Bemegride

Bemegride Sodium

Benapryzine Hydrochloride

Bendrofluazide

Benethamine Penicillin

Benoxaprofen

Benperidol

F25Benserazide

Benserazide Hydrochloride

Bentiromide

Benzathine Penicillin

Benzbromarone

Benzhexol Hydrochloride

Benzilonium Bromide

Benzocaine

Any use except ophthalmic use

Benzoctamine Hydrochloride

Benzoyl Peroxide

10.0 per cent

External

N-Benzoyl Sulphanilamide

Benzquinamide

Benzquinamide Hydrochloride

Benzthiazide

Benztropine Mesylate

Benzylpenicillin Calcium

Benzylpenicillin Potassium

Benzylpenicillin Sodium

Beractant

Betahistine Hydrochloride

Betamethasone

Betamethasone Adamantoate

Betamethasone Benzoate

Betamethasone Dipropionate

Betamethasone Sodium Phosphate

Betamethasone Valerate

Betaxolol Hydrochloride

Bethanechol Chloride

Bethanidine Sulphate

Bezafibrate

F22Bicalutamide

Biperiden Hydrochloride

Biperiden Lactate

Bismuth Glycollylarsanilate

Bisoprolol Fumarate

Bleomycin

Bleomycin Sulphate

Bretylium Tosylate

F25Brimonidine Tartrate

Bromhexine Hydrochloride

Bromocriptine Mesylate

Bromperidol

Bromvaletone

Brotizolam

Budesonide

For nasal administration

200mcg per nostril (MD)

Container or package containing not more than 10mg of Budesonide

For the prevention or treatment of seasonal allergic rhinitis

F34For a maximum period of 3 months

200 mcg per nostril (MDD)

F35For use in persons aged 18 years and over

As a non-aerosol, aqueous form

Bufexamac

Bumetanide

Buphenine Hydrochloride

6mg (MD)

18mg (MDD)

Bupivacaine

Any use except ophthalmic use

Bupivacaine Hydrochloride

Any use except ophthalmic use

Buserelin Acetate

Buspirone Hydrochloride

Busulphan

Butacaine Sulphate

Any use except ophthalmic use

Butorphanol Tartrate

Butriptyline Hydrochloride

F36Cabergoline

Calcipotriol

F22Calcipotriol Hydrate

Calcitonin

Calcitriol

Calcium Amphomycin

Calcium Benzamidosalicylate

Calcium Bromide

Calcium Bromidolactobionate

Calcium Carbimide

Calcium Folinate

Calcium Metrizoate

Calcium Sulphaloxate

F37Candesartan Cilexetil

Candicidin

Canrenoic Acid

Cantharidin

0.01 per cent

External

Capreomycin Sulphate

Captopril

Carbachol

Carbamazepine

Carbaryl

F25Carbasalate Calcium

Carbenicillin Sodium

Carbenoxolone Sodium

(1) Pellet

(1) 5mg (MD)

25mg (MDD)

(2) 2.0 per cent

(2) Gel

(3) 1.0 per cent

(3) Granules for mouthwash in adults and children not less than 12 years

(3) 20mg (MD)

(3) Container or package containing not more than F38560mg of Carbenoxolone Sodium

80mg (MDD)

Carbidopa

Carbimazole

Carbocisteine

Carbon Tetrachloride

Carboplatin

Carboprost Trometamol

Carbuterol Hydrochloride

Carfecillin Sodium

Carindacillin Sodium

Carisoprodol

Carmustine

Carperidine

Carteolol Hydrochloride

Cefaclor

Cefadroxil

Cefazedone Sodium

F25Cefdinir

Cefixime

Cefodizime Sodium

Cefotaxime Sodium

Cefoxitin Sodium

Cefpodoxime Proxetil

F36Cefprozil

Cefsulodin Sodium

Ceftazidime

Ceftizoxime Sodium

Ceftriaxone Sodium

Cefuroxime Axetil

Cefuroxime Sodium

Celiprolol Hydrochloride

Cephalexin

Cephalexin Sodium

Cephaloridine

Cephalothin Sodium

Cephamandole Nafate

Cephazolin Sodium

Cephradine

Cerium Oxalate

Cerivastatin

F25Cerivastatin Sodium

Ceruletide Diethylamine

Cetirizine Hydrochloride

10mg (MDD)

F39. . .

Chenodeoxycholic Acid

Chloral Hydrate

External

Chlorambucil

Chloramphenicol

Chloramphenicol Cinnamate

Chloramphenicol Palmitate

Chloramphenicol Sodium Succinate

Chlorhexadol

Chlormadinone Acetate

Chlormerodrin

Chlormethiazole

Chlormethiazole Edisylate

Chlormezanone

Chloroform20

(1) 5.0 per cent

(1) Internal

(2) External

Chloroquine Phosphate

Prophylaxis of malaria

Chloroquine Sulphate

Prophylaxis of malaria

Chlorothiazide

Chlorotrianisene

Chlorphenoxamine Hydrochloride

Chlorpromazine

Chlorpromazine Embonate

Chlorpromazine Hydrochloride

Chlorpropamide

Chlorprothixene

Chlorprothixene Hydrochloride

Chlortetracycline

Chlortetracycline Calcium

Chlortetracycline Hydrochloride

Chlorthalidone

Chlorzoxazone

Cholestyramine

Ciclacillin

Ciclobendazole

Cilastatin Sodium

Cilazapril

Cimetidine

(a) For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn

(a) 200mg (MD)

800mg (MDD)

For a maximum period of 14 days

(b) For the prophylactic management of nocturnal heartburn by a single dose taken at night

(b) 100mg (MD) to be taken as a single dose at night

For a maximum period of 14 days

Cimetidine Hydrochloride

Cinchocaine

3.0 per cent

Non-ophthalmic use

Cinchocaine Hydrochloride

Equivalent of 3.0 per cent of Cinchocaine

Non-ophthalmic use

Cinchophen

Cinoxacin

Ciprofibrate

Ciprofloxacin

Ciprofloxacin Hydrochloride

Cisapride

Cisplatin

F22Citalopram Hydrobromide

Clarithromycin

Clavulanic Acid

Clidinium Bromide

Clindamycin

Clindamycin Hydrochloride

Clindamycin Palmitate Hydrochloride

Clindamycin Phosphate

Clioquinol

(1) External (other than treatment of mouth ulcers)

(2) 35mg

(2) Treatment of mouth ulcers

(2) 350mg (MDD)

Clobetasol Propionate

Clobetasone Butyrate

F400.05 per cent

F40Cream for use in adults and in children aged 12 years and over, for external use for the short term symptomatic treatment and control of patches of eczema and dermatitis (excluding seborrhoeic dermatitis)

F40Container or package containing not more than 15g of medicinal product

Clofazimine

Clofibrate

Clomiphene Citrate

Clomipramine

Clomipramine Hydrochloride

Clomocycline

Clomocycline Sodium

Clonidine

Clonidine Hydrochloride

Clopamide

Clopenthixol Decanoate

Clopenthixol Hydrochloride

Clorexolone

Clotrimazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Cloxacillin Benzathine

Cloxacillin Sodium

Clozapine

Cocculus Indicus

Co-dergocrine Mesylate

Colaspase

Colchicine

Colestipol Hydrochloride

Colfosceril Palmitate

Colistin Sulphate

Colistin Sulphomethate

Colistin Sulphomethate Sodium

Coniine

Conium Leaf

7.0 per cent

External

Corticotrophin

Cortisone

Cortisone Acetate

Co-tetroxazine

Co-trimoxazole

Cropropamide

Crotethamide

Croton Oil

Croton Seed

Curare

Cyclofenil

Cyclopenthiazide

Cyclopentolate Hydrochloride

Cyclophosphamide

Cycloserine

Cyclosporin

Cyclothiazide

Cyproterone Acetate

Cytarabine

Cytarabine Hydrochloride

Dacarbazine

Dalteparin Sodium

Danazol

Danthron

Dantrolene Sodium

Dapsone

Dapsone Ethane Ortho Sulphonate

Daunorubicin Hydrochloride

Deanol Bitartrate

26mg (MDD)

Debrisoquine Sulphate

Demecarium Bromide

Demeclocycline

Demeclocycline Calcium

Demeclocycline Hydrochloride

Deoxycortone Acetate

Deoxycortone Pivalate

Deptropine Citrate

Dequalinium Chloride

(1) 0.25mg

(1) Internal: throat lozenges or throat pastilles

(2) 1.0 per cent

(2) External: paint

Deserpidine

Desferrioxamine Mesylate

Desflurane

Desipramine Hydrochloride

Deslanoside

Desmopressin

Desmopressin Acetate

Desogestrel

Desonide

Desoxymethasone

Dexamethasone

Dexamethasone Acetate

Dexamethasone Isonicotinate

Dexamethasone Phenylpropionate

Dexamethasone Pivalate

Dexamethasone Sodium Metasulphobenzoate

Dexamethasone Sodium Phosphate

Dexamethasone Troxundate

Dexfenfluramine Hydrochloride

Dextromethorphan Hydrobromide

Internal

(a) In the case of a prolonged release preparation: equivalent of 30mg of Dextromethorphan (MD)

equivalent of 75mg of Dextromethorphan (MDD)

(b) in any other case: equivalent of 15mg of Dextromethorphan (MD)

equivalent of 75mg of Dextromethorphan (MDD)

Dextrothyroxine Sodium

Diazoxide

Dibenzepin Hydrochloride

Dichloralphenazone

Dichlorphenamide

Diclofenac Diethylammonium

1.16 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism

For use in adults and children not less than 12 years

Diclofenac Potassium

Diclofenac Sodium

Dicyclomine Hydrochloride

10mg (MD)

60mg (MDD)

F21Didanosine

Dienoestrol

Diethanolamine Fusidate

Diflucortolone Valerate

Diflunisal

Digitalin

Digitalis Leaf

Digitalis Prepared

Digitoxin

Digoxin

Dihydralazine Sulphate

Dihydroergotamine Mesylate

Dihydrostreptomycin

Dihydrostreptomycin Sulphate

Diloxanide Furoate

Diltiazem Hydrochloride

Dimercaprol

Dimethisoquin Hydrochloride

Non-ophthalmic use

Dimethisterone

Dimethothiazine Mesylate

Dimethyl Sulphoxide

Dimethyltubocurarine Bromide

Dimethyltubocurarine Chloride

Dimethyltubocurarine Iodide

Dinoprost

Dinoprost Trometamol

Dinoprostone

F24Diphenhydramine Hydrochloride

All preparations except liquid-filled capsules

F41Diphenoxylate Hydrochloride

F412.5 mg

F41In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea

F4125 mg (MDD)

F41Container or package containing not more than 20 tablets

For use in persons aged 16 years and over

Tablets

Dipivefrin Hydrochloride

Dipyridamole

Disodium Etidronate

Disodium Pamidronate

Disopyramide

Disopyramide Phosphate

Distigmine Bromide

Disulfiram

Dithranol

1.0 per cent

Dobutamine Hydrochloride

F41Dolasetron Mesilate

Domperidone

F42For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn

F4210mg of Domperidone (MD)

F42Container or package containing not more than 200mg of Domperidone

F4240mg of Domperidone (MDD)

Domperidone Maleate

F43For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn,

F4410 mg of Domperidone as Domperidone Maleate (MD)

F43Container or package containing not more than F45200mg of Domperidone as Domperidone Maleate;

F4440 mg of Domperidone as Domperidone Maleate (MDD)

F25Donepezil Hydrochloride

Dopamine Hydrochloride

Dopexamine Hydrochloride

F22Dorzolamide Hydrochloride

Dothiepin

Dothiepin Hydrochloride

Doxapram Hydrochloride

Doxazosin Mesylate

Doxepin Hydrochloride

Doxorubicin

Doxorubicin Hydrochloride

Doxycycline

Doxycycline Calcium Chelate

Doxycycline Hydrochloride

Droperidol

Dydrogesterone

Dyflos

Econazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Econazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Ecothiopate Iodide

Edrophonium Chloride

Eflornithine Hydrochloride

F21Eformoterol Fumarate

Embutramide

Emepronium Bromide

Emetine

1.0 per cent

Emetine Bismuth Iodide

Emetine Hydrochloride

Equivalent of 1.0 per cent of Emetine

Enalapril Maleate

Encephalitis Virus, Tick-borne, Cent Eur

Enoxacin

Enoxaparin Sodium

Enoximone

Ephedrine

(1) Internal (other than nasal sprays or nasal drops)

(1) 30mg (MD)

60mg (MDD)

(2) 2.0 per cent

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Hydrochloride

(1) Internal (other than nasal sprays or nasal drops)

(1) Equivalent of 30mg of Ephedrine (MD)

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Ephedrine Sulphate

(1) Internal (other than nasal sprays or nasal drops)

(1) Equivalent of 30mg of Ephedrine (MD)

Equivalent of 60mg of Ephedrine (MDD)

(2) Equivalent of 2.0 per cent of Ephedrine

(2) Nasal sprays or nasal drops

(3) External

Epicillin

Epirubicin

Epirubicin Hydrochloride

Epithiazide

Epoetin Alfa

Epoetin Beta

Epoprostenol Sodium

Ergometrine Maleate

Ergometrine Tartrate

Ergot, Prepared

Ergotamine Tartrate

Erythromycin

Erythromycin Estolate

Erythromycin Ethylcarbonate

Erythromycin Ethyl Succinate

Erythromycin Lactobionate

Erythromycin Phosphate

Erythromycin Stearate

Erythromycin Thiocyanate

Esmolol Hydrochloride

Estramustine Phosphate

F46Estramustine Sodium Phosphate

Etafedrine Hydrochloride

Ethacrynic Acid

Ethambutol Hydrochloride

Ethamivan

Ethamsylate

Ethiazide

Ethinyl Androstenediol

Ethinyloestradiol

Ethionamide

Ethisterone

Ethoglucid

Ethoheptazine Citrate

Ethopropazine Hydrochloride

Ethosuximide

Ethotoin

Ethyl Biscoumacetate

Ethynodiol Diacetate

Etodolac

Etomidate

Etomidate Hydrochloride

Etoposide

Etretinate

F22Exemestane

Famciclovir

Famotidine

For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms

10mg (MD)

20mg (MDD)

For maximum period of 14 days

Fazadinium Bromide

Felbinac

3.17 per cent

External

For maximum period of 7 days

Container or package containing not more than F4750g of medicinal product

F48For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions

For use in adults and children not less than 12 years

Felodipine

Felypressin

Fenbufen

Fenclofenac

Fenfluramine Hydrochloride

Fenofibrate

Fenoprofen

Fenoprofen Calcium

Fenoterol Hydrobromide

Fenticonazole Nitrate

F40External use (but in the case of vaginal use, only for the treatment of vaginal candidiasis)

Feprazone

Ferrous Arsenate

F22Ferumoxsil

F25Fexofenadine Hydrochloride

Filgrastim

Finasteride

Flavoxate Hydrochloride

Flecainide Acetate

Flosequinan

Fluanisone

Flubendazole

Fluclorolone Acetonide

Flucloxacillin Magnesium

Flucloxacillin Sodium

Fluconazole

For oral administration for the treatment of vaginal candidiasis F49or associated candidal balanitis in persons aged not less than 16 but less than 60 years

150mg (MD)

Container or package containing not more than 150mg of Fluconazole

Flucytosine

Fludrocortisone Acetate

Flufenamic Acid

Flumazenil

Flumethasone

Flumethasone Pivalate

Flunisolide

0.025 per cent

(a) For the prevention and treatment of seasonal allergic rhinitis, including hay fever

(a) 50mcg per nostril (MD)

(a) Container or package containing not more than 6,000mcg of Flunisolide

100mcg per nostril (MDD)

F50For use in persons aged 18 years and over

F51For a maximum period of 3 months

In the form of a non-pressurised nasal spray

F52...

F52...

F52...

F52. . .

F52. . .

F52. . .

Fluocinolone Acetonide

Fluocinonide

Fluocortin Butyl

Fluocortolone

Fluocortolone Hexanoate

Fluocortolone Pivalate

Fluorescein Dilaurate

Fluorometholone

Fluorouracil

Fluorouracil Trometamol

Fluoxetine Hydrochloride

Flupenthixol Decanoate

Flupenthixol Hydrochloride

Fluperolone Acetate

Fluphenazine Decanoate

Fluphenazine Enanthate

Fluphenazine Hydrochloride

Fluprednidene Acetate

Fluprednisolone

Fluprostenol Sodium

Flurandrenolone

Flurbiprofen

F538.75 mg

F54Throat lozenges

F5543.75 mg (MDD)

F56Container or package containing not more than 140 mg of Flurbiprofen

Flurbiprofen Sodium

Fluspirilene

Flutamide

Fluticasone Propionate

F25Flutrimazole

Fluvastatin Sodium

Fluvoxamine Maleate

Folic Acic

500mcg (MDD)

Formestane

Formocortal

Foscarnet Sodium

Fosfestrol Sodium

Fosfomycin Trometamol

Fosinopril Sodium

Framycetin Sulphate

Frusemide

Furazolidone

Fusafungine

Fusidic Acid

Gabapentin

Gadoteridol

Gallamine Triethiodide

Ganciclovir

Ganciclovir Sodium

Gelsemine

0.1 per cent

Gelsemium

25mg (MD)

75mg (MDD)

Gemeprost

Gemfibrozil

Gentamicin

Gentamicin Sulphate

Gestodene

Gestrinone

Gestronol

Gestronol Hexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Gliquidone

Glisoxepide

Glucagon

Glycopyrronium Bromide

1mg (MD)

2mg (MDD)

Glymidine

Gonadorelin

Goserelin Acetate

Gramicidin

0.2 per cent

External

Granisetron Hydrochloride

Griseofulvin

Growth Hormone

Guanethidine Monosulphate

Guanfacine Hydrochloride

Guanoclor Sulphate

Guanoxan Sulphate

Halcinonide

Halofantrine Hydrochloride

Haloperidol

Haloperidol Decanoate

Heparin

External

Heparin Calcium

External

Heparin Sodium

Hexachlorophane

External

(a) 2.0 per cent

(a) Soaps

(b) 0.1 per cent

(b) Aerosols

(c) 0.75 per cent

(c) preparations other than soaps and aerosols

Hexamine Phenylcinchoninate

Hexobarbitone

Hexobarbitone Sodium

Hexoestrol

Hexoestrol Dipropionate

L-Histidine Hydrochloride

Dietary supplementation

Homatropine

(1) Internal

(1) 0.15mg (MD)

0.45mg (MDD)

(2) External (except ophthalmic)

Homatropine Hydrobromide

0.2mg (MD)

0.6mg (MDD)

Homatropine Methylbromide

2mg (MD)

6mg (MDD)

Hydralazine Hydrochloride

Hydrargaphen

Local application to skin

Hydrobromic Acid

Hydrochlorothiazide

Hydrocortisone

F57(1)

0.5 per cent

F57(1)

External

  1. (a)

    For use in combination with Nystatin of maximum strength 3.0 per cent for intertrigo

  2. (b)

    For use in adults and children not less than 10 years

F57(1)

Container or package containing not more than 15g of medicinal product

F58(2)

1.0 per cent

F58(2)

External

  1. (a)

    For use either alone or in conjunction with Crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with Clotrimazole F59or Miconazole Nitrate for athlete’s foot and candidal intertrigo or in combination with lignocaine for anal and perianal itch associated with haemorrhoids

  2. (b)

    For use in adults and children not less than 10 years

  3. (c)

    Cream ointment or spray

F58(2)

Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray)

Hydrocortisone Acetate

Equivalent to 1.0 per cent Hydrocortisone

External

For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with one or more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for haemorrhoids F60or in combination with Miconazole Nitrate, for athlete’s foot and candidal intertrigo

Container or package containing not more than 15g of medicinal product

In the case of suppositories, container or package containing no more than 12

For use in adults and children not less than 10 years

Cream, ointment or suppositories

Hydrocortisone Butyrate

Hydrocortisone Caprylate

Hydrocortisone Hydrogen Succinate

Hydrocortisone Sodium Phosphate

Hydrocortisone Sodium Succinate

Equivalent to 2.5mg Hydrocortisone

External

Container or package containing not more than equivalent to 50mg of Hydrocortisone

For aphthous ulceration of the mouth for adults and children not less than 12 years

In the form of pellets

F24Hydrocyanic Acid

Hydroflumethiazide

Hydroxychloroquine Sulphate

Prophylaxis of malaria

Hydroxyprogesterone

Hydroxyprogesterone Enanthate

Hydroxyprogesterone Hexanoate

Hydroxyurea

Hydroxyzine Embonate

Hydroxyzine Hydrochloride

(a) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children not less than 12 years

(a) 25mg (MD)

(a) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

75mg (MDD)

(b) For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in children not less than 6 years but less than 12 years

(b) 25 mg (MD)

(b) Container or package containing not more than 750mg of Hydroxyzine Hydrochloride

50mg (MDD)

Hyoscine

(1) 0.15 per cent

(1) Internal

(2) External (except ophthalmic)

Hyoscine Butylbromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 20mg (MD)

(b) Container or package containing not more than 240mg of Hyoscine Butylbromide

80mg (MDD)

(2) External

Hyoscine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

900mcg (MDD)

(2) External (except ophthalmic)

Hyoscine Methobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscine Methonitrate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 2.5mg (MD)

7.5mg (MDD)

(2) External

Hyoscyamine

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD)

1mg (MDD)

(2) External

Hyoscyamine Hydrobromide

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Hyoscyamine Sulphate

(1) Internal

(a) by inhaler

(b) otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD)

Equivalent of 1mg of Hyoscyamine (MDD)

(2) External

Ibuprofen

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(1) Internal

(1)(a) In the case of a prolonged release preparation 600mg (MD)

1,200mg (MDD)

(b) in any other case 400mg (MD)

1,200mg (MDD)

(2) 5.0 per cent

(2) External

F61(3) 10.0 per cent

F61(3) External

F61(3) 125 mg (MD) 500 mg (MDD)

F61(3) Container or package containing not more than F6250g of medicinal product

F24Ibuprofen Lysine

Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(a) in the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)

Internal

(b) in any other case 400 mg (MD) 1,200 mg (MDD)

Idarubicin Hydrochloride

Idoxuridine

Ifosfamide

Ignatius Bean

F21Imidapril Hydrochloride

Imipenem Hydrochloride

Imipramine

Imipramine Hydrochloride

Imipramine Ion Exchange Resin Bound Salt or Complex

F36Indapamide

Indapamide Hemihydrate

Indomethacin

Indomethacin Sodium

Indoprofen

Indoramin Hydrochloride

Inosine Pranobex

F63Insulin

Iodamide

Iodamide Meglumine

Iodamide Sodium

Iohexol

Iomeprol

Iopamidol

Iopentol

Iothalamic Acid

Ioversol

Ioxaglic Acid

Ipratropium Bromide

Iprindole Hydrochloride

Iproniazid Phosphate

F25Irbesartan

Isoaminile

Isoaminile Citrate

Isocarboxazid

Isoconazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Isoetharine

Isoetharine Hydrochloride

Isoetharine Mesylate

Isoniazid

Isoprenaline Hydrochloride

Isoprenaline Sulphate

Isopropamide Iodide

Equivalent of 2.5mg of Isopropamide ion (MD)

Equivalent of 5.0mg of Isopropamide ion (MDD)

Isotretinoin

Isradipine

Itraconazole

Jaborandi

External

Kanamycin Acid Sulphate

Kanamycin Sulphate

Ketamine Hydrochloride

Ketoconazole

2.0 per cent

F64(a)F65External

F64(a) Maximum frequency of application of once every 3 days

F64(a) Container or package containing not more than 120ml of medicinal product and containing not more than 2,400mg of Ketoconazole

For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp

In the form of a shampoo

F66(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo

Ketoprofen

2.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For rheumatic and muscular pain in adults and children not less than 12

Ketorolac Trometamol

Ketotifen Fumarate

Labetalol Hydrocholoride

Lachesine Chloride

Lacidipine

Lamotrigine

Lanatoside C

Lanatoside Complex A, B and C

F36Lansoprazole

Latamoxef Disodium

F36Lercanidipine Hydrochloride

Levallorphan Tartrate

Levobunolol Hydrochloride

F24Levocabastine Hydrochloride

Equivalent of 0.05 per cent Levocabastine

(1) Nasal sprays

(1) Container or package containing not more than 10 ml of medicinal product

For the symptomatic treatment of seasonal allergic rhinitis

(2) Aqueous eye drops

(2) Container or package containing not more than 4 ml of medicinal product

For the symptomatic treatment of seasonal allergic conjunctivitis

F67Levocarnitine

F67For dietary supplementation

Levodopa

F25Levofloxacin

Levonorgestrel

F680.75mg

F68for use as an emergency contraceptive in women aged 16 years and over

Lidoflazine

Lignocaine

Non-ophthalmic use

Lignocaine Hydrochloride

Non-ophthalmic use

Lincomycin

Lincomycin Hydrochloride

Liothyronine Sodium

Lisinopril

Lithium Carbonate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lithium Citrate

Lithium Succinate

Lithium Sulphate

Equivalent of 5mg of Lithium (MD)

Equivalent of 15mg of Lithium (MDD)

Lobeline

(1) Internal

(1) 3mg (MD)

9mg (MDD)

(2) External

Lobeline Hydrochloride

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lobeline Sulphate

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD)

Equivalent of 9mg of Lobeline (MDD)

(2) External

Lodoxamide Trometamol

F69equivalent of 0.1 per cent Lodoxamide

F70For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over

Lofepramine

Lofepramine Hydrochloride

Lofexidine Hydrochloride

Lomefloxacin Hydrochloride

Lomustine

Loperamide Hydrochloride

Treatment of acute diarrhoea

Loratidine

10mg (MDD)

F71. . .

F37Lornoxicam

F37Losartan Potassium

Loxapine Succinate

Lung Surfactant Porcine

Luteinising Hormone

Lymecycline

Lynoestrenol

Lypressin

Lysuride Maleate

Mafenide

Mafenide Acetate

Mafenide Hydrochloride

Mafenide Propionate

5.0 per cent

Eye drops

Magnesium Fluoride

Magnesium Metrizoate

Mandragora Autumnalis

Mannomustine Hydrochloride

Maprotiline Hydrochloride

Mebanazine

Mebendazole

For oral use in the treatment of enterobiasis in adults and in children not less than 2 years

100mg (MD)

Container or package containing not more than 800mg of Mebendazole

Mebeverine Hydrochloride

F72(a)

For the symptomatic relief of irritable bowel syndrome

F72(a)

135 mg (MD)

405 mg (MDD)

(b)

For uses other than the symptomatic relief of irritable bowel syndrome

F72(b)

100 mg (MD)

300 mg (MDD)

Mebeverine Pamoate

Mebhydrolin

Mebhydrolin Napadisylate

Mecamylamine Hydrochloride

Mecillinam

Meclofenoxate Hydrochloride

Medigoxin

Medrogestone

Medroxyprogesterone Acetate

Mefenamic Acid

Mefloquine Hydrochloride

Mefruside

Megestrol

Megestrol Acetate

Meglumine Gadopentetate

Meglumine Iodoxamate

Meglumine Ioglycamate

Meglumine Iothalamate

Meglumine Iotroxate

Meglumine Ioxaglate

F36Meloxicam

Melphalan

Melphalan Hydrochloride

Menotrophin

Mepenzolate Bromide

25mg (MD)

75mg (MDD)

Mephenesin

Mephenesin Carbamate

Mepivacaine Hydrochloride

Any use except ophthalmic use

Meptazinol Hydrochloride

Mequitazine

F25Mercaptamine Bitartrate

Mercaptopurine

Mersalyl

Mersalyl Acid

Mesalazine

Mesna

Mestranol

Metaraminol Tartrate

Metergoline

Metformin Hydrochloride

Methacycline

Methacycline Calcium

Methacycline Hydrochloride

Methallenoestril

Methicillin Sodium

Methixene

Methixene Hydrochloride

Methocarbamol

Methocidin

Throat lozenges and throat pastilles

Methohexitone Sodium

Methoin

Methoserpidine

Methotrexate

Methotrexate Sodium

Methotrimeprazine

Methotrimeprazine Hydrochloride

Methotrimeprazine Maleate

Methoxamine Hydrochloride

0.25 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Methsuximide

Methyclothiazide

Methyldopa

Methyldopate Hydrochloride

Methylephedrine Hydrochloride

30mg (MD)

60mg (MDD)

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Sodium Succinate

Methylthiouracil

Methysergide Maleate

Metipranolol

Metirosine

Metoclopramide Hydrochloride

Metolazone

Metoprolol Fumarate

Metoprolol Succinate

Metoprolol Tartrate

Metronidazole

Metronidazole Benzoate

Metyrapone

Mexiletine Hydrochloride

Mezlocillin Sodium

Mianserin Hydrochloride

Miconazole

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Miconazole Nitrate

External but in the case of vaginal use only external use for the treatment of vaginal candidiasis

Mifepristone

Miglitol

Milrinone

Milrinone Lactate

Minocycline

Minocycline Hydrochloride

Minoxidil

F73(1) 2.0 per cent

F73(1) External

F73(2) 5.0 per cent

(2) External use for the treatment of alopecia androgenetica, in men aged 18 to 65 (but not in women);

F21Mirtazapine

Misoprostol

Mitobronitol

Mitomycin

Mitozantrone Hydrochloride

Mivacurium Chloride

F46Mizolastine

Moclobemide

F25Modafinil

F22Moexipril Hydrochloride

Molgramostim

Molindone Hydrochloride

Mometasone Furoate

Moracizine Hydrochloride

Morazone Hydrochloride

F21Moxonidine

Mupirocin

Mupirocin Calcium

Mustine Hydrochloride

Nabilone

Nabumetone

Nadolol

Nafarelin Acetate

Naftidrofuryl Oxalate

Naftifine Hydrochloride

Nalbuphine Hydrochloride

Nalidixic Acid

Nalorphine Hydrobromide

Naloxone Hydrochloride

Naltrexone Hydrochloride

Naphazoline Hydrochloride

(1) 0.05 per cent

(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

(2) 0.015 per cent

(2) Eye drops

Naphazoline Nitrate

0.05 per cent

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Naproxen

Naproxen Sodium

F25Naratriptan Hydrochloride

Natamycin

F37Nebivolol Hydrochloride

Nedocromil Sodium

F742.0 per cent

F74For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis

F74Container or package containing not more than 3 ml of medicinal product

Nefazodone Hydrochloride

Nefopam Hydrochloride

Neomycin

Neomycin Oleate

Neomycin Palmitate

Neomycin Sulphate

Neomycin Undecanoate

Neostigmine Bromide

Neostigmine Methylsulphate

Netilmicin Sulphate

Nicardipine Hydrochloride

Nicergoline

F46Niceritrol

Nicotinic Acid

Any use, except for the treatment of hyperlipidaemia

600mg (MDD)

Nicoumalone

Nifedipine

Nifenazone

Nikethamide

F24Nilutamide

Nimodipine

Niridazole

F37Nisoldipine

Nitrendipine

Nitrofurantoin

Nitrofurazone

Nizatidine

For the prevention F75and treatment of the symptoms of food-related heartburn F75and meal-induced indigestion

75mg (MD)

F76150mg (MDD)

F77For a maximum period of 14 days

For use in adults and children not less than 16 years

Nomifensine Maleate

Noradrenaline

Noradrenaline Acid Tartrate

Norethisterone

Norethisterone Acetate

Norethisterone Enanthate

Norethynodrel

Norfloxacin

Norgestimate

Norgestrel

Nortriptyline Hydrochloride

Noscapine

Noscapine Hydrochloride

Novobiocin Calcium

Novobiocin Sodium

Nux Vomica Seed

Nystatin

F783.0 per cent

F78External

F78Container or package containing not more than 15g of medicinal product

For use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo

For use in adults and children not less than 10 years

Octacosactrin

Octreotide

Oestradiol

Oestradiol Benzoate

Oestradiol Cypionate

Oestradiol Dipropionate

Oestradiol Diundecanoate

Oestradiol Enanthate

Oestradiol Phenylpropionate

Oestradiol Undecanoate

Oestradiol Valerate

Oestriol

Oestriol Succinate

Oestrogenic Substances Conjugated

Oestrone

Ofloxacin

Olsalazine Sodium

Omeprazole

F21Omeprazole Magnesium

Ondansetron Hydrochloride

Orciprenaline Sulphate

Orphenadrine Citrate

Orphenadrine Hydrochloride

Ouabain

Ovarian Gland Dried

Oxamniquine

Oxantel Embonate

Oxaprozin

Oxatomide

Oxedrine Tartrate

Oxethazaine

10mg (MD)

Container or package containing not more than 400mg of Oxethazaine

30mg (MDD)

Oxitropium Bromide

Oxolinic Acid

Oxpentifylline

Oxprenolol Hydrochloride

Oxybuprocaine Hydrochloride

Non-ophthalmic use

Oxybutynin Hydrochloride

Oxypertine

Oxypertine Hydrochloride

Oxyphenbutazone

Oxyphencyclimine Hydrochloride

Oxyphenonium Bromide

5mg (MD)

15mg (MDD)

Oxytetracycline

Oxytetracycline Calcium

Oxytetracycline Dihydrate

Oxytetracycline Hydrochloride

Oxytocin, natural

Oxytocin, synthetic

Pancreatin

(1) 21,000 European Pharmacopoeia units of lipase per capsule

(1) capsules

(2) 25,000 European Pharmacopoeia units of lipase per gram

(2) powder

Pancuronium Bromide

F36Pantoprazole Sodium

Papaverine

(1) By inhaler

(2) Otherwise than by inhaler

(2) 50mg (MD)

150mg (MDD)

Papaverine Hydrochloride

(1) By inhaler

(2) Otherwise than by inhaler

(2) Equivalent of 50mg of Papaverine (MD)

Equivalent of 150mg of Papaverine (MDD)

F26Paracetamol

(1)

F79250mg

(1)

Non-effervescent tablets and capsules F80wholly or mainly for use in children aged less than 12 years

(1)

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

(2)

500 mg

(2)

Non-effervescent tablets and capsules F81wholly or mainly for use in adults and children not less than 12 years

(3)

All preparations other than non-effervescent tablets and capsules

(2)

The quantity sold or supplied in one container or package shall not exceed 32

  • The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100

Paraldehyde

Paramethadione

Paramethasone Acetate

Parathyroid Gland

Pargyline Hydrochloride

Paroxetine Hydrochloride

Pecilocin

Penamecillin

Penbutolol Sulphate

F36Penciclovir

Penicillamine

Penicillamine Hydrochloride

Pentamidine Isethionate

Penthienate Bromide

5mg (MD)

15mg (MDD)

Pentolinium Tartrate

Perfluamine

Pergolide Mesylate

Perhexiline Maleate

Pericyazine

Perindopril

Perindopril Erbumine

Perphenazine

Phenacetin

0.1 per cent

Phenazone

External

Phenazone Salicylate

Phenbutrazate Hydrochloride

Phenelzine Sulphate

Phenethicillin Potassium

Phenformin Hydrochloride

Phenglutarimide Hydrochloride

Phenindione

F82Phenolphthalein.

Phenoxybenzamine Hydrochloride

Phenoxymethylpenicillin

Phenoxymethylpenicillin Calcium

Phenoxymethylpenicillin Potassium

Phenprocoumon

Phensuximide

Phentolamine Hydrochloride

Phentolamine Mesylate

Phenylbutazone

Phenylbutazone Sodium

Phenylpropanolamine Hydrochloride

Internal

(1) all preparations except prolonged release capsules, nasal sprays and nasal drops

(1) 25mg (MD)

100mg (MDD)

(2) prolonged release capsules

(2) 50mg (MD)

100mg (MDD)

(3) 2.0 per cent

(3) nasal sprays and nasal drops

Phenytoin

Phenytoin Sodium

Phthalylsulphathiazole

Physostigmine

Physostigmine Aminoxide Salicylate

Physostigmine Salicylate

Physostigmine Sulphate

F24Phytomenadione

Any use except the prevention or treatment of haemorrhagic disorders

Picrotoxin

Pilocarpine

Pilocarpine Hydrochloride

Pilocarpine Nitrate

Pimozide

Pindolol

Pipenzolate Bromide

5mg (MD)

15mg (MDD)

Piperacillin Sodium

Piperazine Oestrone Sulphate

Piperidolate Hydrochloride

50mg (MD)

150mg (MDD)

Pipothiazine Palmitate

Piracetam

Pirbuterol Acetate

Pirbuterol Hydrochloride

F83Pirenzepine Dihydrochloride Monohydrate

Pirenzepine Hydrochloride

Piretanide

Piroxicam

0.5 per cent

External

For maximum period of 7 days

Container or package containing not more than 30g of medicinal product

For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains and sports injuries

For use in adults and children not less than 12 years

F46Piroxicam Beta-cyclodextrin

Pituitary Gland (Whole Dried)

By inhaler

Pituitary Powdered (Posterior Lobe)

By inhaler

Pivampicillin

Pivampicillin Hydrochloride

Pivmecillinam

Pivmecillinam Hydrochloride

Pizotifen

Pizotifen Malate

Plicamycin

Podophyllotoxin

Podophyllum

Podophyllum Indian

Podophyllum Resin

20.0 per cent

External

Ointment or impregnated plaster

Poldine Methylsulphate

2mg (MD)

6mg (MDD)

Polidexide

Polyestradiol Phosphate

Polymyxin B Sulphate

Polythiazide

Poppy Capsule

Potassium Arsenite

0.0127 per cent

Potassium Bromide

Potassium Canrenoate

Potassium Clavulanate

Potassium Perchlorate

Practolol

Pralidoxime Chloride

Pralidoxime Iodide

Pralidoxime Mesylate

F25Pramipexole Hydrochloride

Pravastatin Sodium

Prazosin Hydrochloride

Prednisolone

Prednisolone Acetate

Prednisolone Butylacetate

Prednisolone Hexanoate

Prednisolone Metasulphobenzoate

Prednisolone Metasulphobenzoate Sodium

Prednisolone Pivalate

Prednisolone Sodium Phosphate

Prednisolone Steaglate

Prednisone

Prednisone Acetate

Prenalterol Hydrochloride

Prenylamine Lactate

Prilocaine Hydrochloride

Non-ophthalmic use

Primidone

Probenecid

Probucol

Procainamide Hydrochloride

Procaine Hydrochloride

Non-ophthalmic use

Procaine Penicillin

Procarbazine Hydrochloride

Prochlorperazine

Prochlorperazine Edisylate

Prochlorperazine Maleate

F403mg

F40Buccal tablets for the treatment of nausea and vomiting in cases of previously diagnosed migraine only. For use in persons aged 18 years and over.

F4012mg (MDD)

F40Container or package containing not more than 8 tablets

Prochlorperazine Mesylate

Procyclidine Hydrochloride

Progesterone

Prolactin

Proligestone

Prolintane Hydrochloride

Promazine Embonate

Promazine Hydrochloride

Propafenone

Propafenone Hydrochloride

Propanidid

Propantheline Bromide

15mg (MD)

45mg (MDD)

F37Propiverine Hydrochloride

Propofol

Propranolol Hydrochloride

Propylthiouracil

Proquazone

Protamine Sulphate

Prothionamide

Protirelin

Protriptyline Hydrochloride

Proxymetacaine Hydrochloride

Non-ophthalmic use

Pseudoephedrine Hydrochloride

Internal

(a) In the case of a prolonged release preparation

120mg (MD)

240mg (MDD)

(b) in any other case 60mg (MD)

240mg (MDD)

Pseudoephedrine Sulphate

60mg (MD)

180mg (MDD)

Pyrantel Embonate

(a) For the treatment of enterobiosis, in adults and children not less than 12 years

(a) 750mg MDD (as a single dose)

(a) Container or package containing not more than 750mg of Pyrantel Embonate

(b) For the treatment of enterobiosis, in children less than 12 years but not less than 6 years

(b) 500mg MDD (as a single dose)

(b) Container or package containing not more than 750mg of Pyrantel Embonate

(c) For the treatment of enterobiosis in children less than 6 years but not less than 2 years

(c) 250mg MDD (as a single dose)

(c) Container or package containing not more than 750mg of Pyrantel Embonate

Pyrantel Tartrate

Pyrazinamide

Pyridostigmine Bromide

Pyrimethamine

F37Quetiapine Fumarate

F22Quinagolide Hydrochloride

Quinapril

F83Quinapril Hydrochloride

Quinestradol

Quinestrol

Quinethazone

Quinidine

Quinidine Bisulphate

Quinidine Polygalacturonate

Quinidine Sulphate

Quinine

100mg (MD)

300mg (MDD)

Quinine Bisulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Cinchophen

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Dihydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Ethyl Carbonate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Glycerophosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrobromide

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Hydrochloride

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Iodobismuthate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Phosphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Salicylate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Sulphate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Tannate

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine in combination with Urea Hydrochloride

Ramipril

F21Ranitidine Bismuth Citrate

Ranitidine Hydrochloride

For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity F84or the prevention of these symptoms when associated with consuming food and drink

Equivalent to 75mg of Ranitidine (MD)

Equivalent to 300mg of Ranitidine (MDD)

For a maximum period of 14 days

Rauwolfia Serpentina

Rauwolfia Vomitoria

Razoxane

F25Reboxetine Mesilate

Remoxipride Hydrochloride

Reproterol Hydrochloride

Rescinnamine

Reserpine

Rifabutin

Rifampicin

Rifampicin Sodium

Rifamycin

F21Rimexolone

Rimiterol Hydrobromide

Risperidone

Ritodrine Hydrochloride

Rolitetracycline Nitrate

F41Ropinirole Hydrochloride

Sabadilla

Salbutamol

Salbutamol Sulphate

Salcatonin

Salcatonin Acetate

Salmefamol

Salmeterol Xinafoate

Salsalate

Saralasin Acetate

Selegiline Hydrochloride

Semisodium Valproate

F25Sertindole

F21Sertraline Hydrochloride

Serum Gonadotrophin

F21Sevoflurane

Silver Sulphadiazine

Simvastatin

Sissomicin

Sissomicin Sulphate

Snake Venoms

Sodium Acetrizoate

Sodium Aminosalicylate

Sodium Antimonylgluconate

Sodium Arsanilate

Sodium Arsenate

Sodium Arsenite

0.013 per cent

Sodium Bromide

Sodium Clodronate

Sodium Cromoglycate

(a) For nasal admistration

(b) 2.0 per cent

(b) For the treatment of acute seasonal allergic conjunctivitis F85or perennial allergic conjunctivitis

(b) Container or package containing not more than 10ml of medicinal product

In the form of aqueous eye drops

(c) 4.0 per cent

(c) For the treatment of acute seasonal allergic conjunctivitis

(c) Container or package containing not more than 5g of medicinal product

In the form of an eye ointment

Sodium Ethacrynate

Sodium Fluoride

(1) 0.33 per cent

(1) Dentifrices

(2) Other preparations for use in the prevention of dental caries

In the form of

(a) tablets or drops

(a) 2.2 mg (MDD)

(b) 0.2 per cent

(b) mouth rinses other than those for daily use

(c) 0.05 per cent

(c) mouth rinses for daily use

Sodium Fusidate

Sodium Metrizoate

Sodium Monofluorophosphate

1.14 per cent

Dentrifrice

Sodium Oxidronate

Sodium Stibogluconate

Sodium Valproate

Somatorelin Acetate

Sotalol Hydrochloride

F22Sparfloxacin

Spectinomycin

Spectinomycin Hydrochloride

Spiramycin

Spiramycin Adipate

Spironolactone

Stannous Fluoride

(F861) 0.62 per cent

(F861) Dentifrice

F86(2) 0.4 per

F86(2) Dental gels for use in the prevention and treatment of dental caries and decalcification of the teeth

Stilboestrol

Stilboestrol Dipropionate

Streptodornase

External

Streptokinase

External

Streptomycin

Streptomycin Sulphate

Strychnine

Strychnine Arsenate

Strychnine Hydrochloride

F24Strychnine Nitrate

Styramate

Succinylsulphathiazole

Sucralfate

Sulbactam Sodium

Sulbenicillin

Sulbenicillin Sodium

Sulconazole Nitrate

External (except vaginal)

F24Sulfabenzamide

Sulfacytine

Sulfadoxine

Sulfamerazine

Sulfamerazine Sodium

Sulfametopyrazine

Sulfamonomethoxine

Sulindac

Sulphacetamide

Sulphacetamide Sodium

Sulphadiazine

Sulphadiazine Sodium

Sulphadimethoxine

Sulphadimidine

Sulphadimidine Sodium

Sulphafurazole

Sulphafurazole Diethanolamine

Sulphaguanidine

Sulphaloxic Acid

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamethoxypyridazine Sodium

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphapyridine

Sulphapyridine Sodium

Sulphasalazine

Sulphathiazole

Sulphathiazole Sodium

Sulphaurea

Sulphinpyrazone

Sulpiride

Sultamicillin

Sultamicillin Tosylate

Sulthiame

Sumatriptan Succinate

Suprofen

Suxamethonium Bromide

Suxamethonium Chloride

Suxethonium Bromide

F37Tacalcitol Monohydrate

Tacrine Hydrochloride

Talampicillin

Talampicillin Hydrochloride

Talampicillin Napsylate

Tamoxifen

Tamoxifen Citrate

F36Tamsulosin Hydrochloride

F21Tazarotene

Tazobactam Sodium

Teicoplanin

F25Temocapril Hydrochloride

Temocillin Sodium

Tenoxicam

Terazosin Hydrochloride

Terbinafine

F871.0 per cent

F88External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel

F89Container or package containing not more than 30 grams of medicinal product

F90Terbinafine Hydrochloride

F901.0 per cent

(F911) F92Preparations, other than spray solutions, forF90external use for the treatment of tinea pedis and tinea cruris

(F911) F90Container or package containing not more than 15 g of medicinal product.

F93(2) Spray solutions for external use for the treatment of tinea corporis, tinea cruris and tinea pedis

F93(2) Container containing not more than 30ml of medicinal product

Terbutaline

Terbutaline Sulphate

Terfenadine

F94. . .

F94...

Terlipressin

Terodiline Hydrochloride

F25Testosterone

Tetrabenazine

Tetracosactrin

Tetracosactrin Acetate

Tetracycline

Tetracycline Hydrochloride

Tetracycline Phosphate Complex

Tetroxoprim

Thallium Acetate

Thallous Chloride

Thiabendazole

Thiambutosine

Thiethylperazine Malate

Thiethylperazine Maleate

Thiocarlide

Thioguanine

Thiopentone Sodium

Thiopropazate Hydrochloride

Thioproperazine Mesylate

Thioridazine

Thioridazine Hydrochloride

Thiosinamine

Thiotepa

Thiothixene

Thiouracil

Thymoxamine Hydrochloride

Thyroid

Thyrotrophin

Thyroxine Sodium

Tiamulin Fumarate

Tiaprofenic Acid

Tibolone

Ticarcillin Sodium

F36Ticlopidine Hydrochloride

Tigloidine Hydrobromide

F36Tiludronate Disodium

Timolol Maleate

Tinidazole

Tinzaparin

Tioconazole

(1) 2.0 per cent

(1) External (except vaginal)

(2) Vaginal for treatment of vaginal candidiasis

F22Tizanidine Hydrochloride

Tobramycin

Tobramycin Sulphate

Tocainide Hydrochloride

Tofenacin Hydrochloride

Tolazamide

Tolazoline Hydrochloride

External

Tolbutamide

Tolbutamide Sodium

Tolfenamic Acid

Tolmetin Sodium

F21Topiramate

F46Torasemide

F36Toremifene

Tramadol Hydrochloride

Trandolapril

Tranexamic Acid

Tranylcypromine Sulphate

Trazodone Hydrochloride

Treosulfan

Tretinoin

Triamcinolone

Triamcinolone Acetonide

F95(1) 0.1 per cent

F95(1) For the treatment of common mouth ulcers

F95(1) Container or package containing not more than 5g of medicinal product

F96(2) In the form of a non-pressurised nasal spray, for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over

F96(2) 110mcg per nostril (MD)

F96Container or package containing not more than 3.575mg of Triamcinolone Acetonide

110mcg per nostril (MDD)

For a maximum period of 3 months

Triamcinolone Diacetate

Triamcinolone Hexacetonide

Triamterene

Tribavirin

Triclofos Sodium

Trientine Dihydrochloride

Trifluoperazine

Trifluoperazine Hydrochloride

Trifluperidol

Trifluperidol Hydrochloride

Trilostane

Trimeprazine

Trimeprazine Tartrate

Trimetaphan Camsylate

Trimetazidine

Trimetazidine Hydrochloride

Trimethoprim

Trimipramine Maleate

Trimipramine Mesylate

Tropicamide

Tropisetron Hydrochloride

Troxidone

L-Tryptophan

(1) Oral

Dietary supplementation

(2) External

Tubocurarine Chloride

Tulobuterol

Tulobuterol Hydrochloride

Tyrothricin

Throat lozenges or throat pastilles

Uramustine

Urea Stibamine

Urethane

Uridine 5'-triphosphate

Urofollitrophin

Urokinase

Ursodeoxychoic Acid

Vaccine: Bacillus Salmonella Typhi

Vaccine: Poliomyelitis (Oral)

F22Valaciclovir Hydrochloride

Valproic Acid

F25Valsartan

Vancomycin Hydrochloride

Vasopressin

Vasopressin Tannate

Vecuronium Bromide

F22Venlafaxine Hydrochloride

Verapamil Hydrochloride

Veratrine

Veratrum, Green

Veratrum, White

Vidarabine

Vigabatrin

Viloxazine Hydrochloride

Vinblastine Sulphate

Vincristine Sulphate

Vindesine Sulphate

Viomycin Pantothenate

Viomycin Sulphate

Vitamin A

(1) Internal

(1) 7,500iu (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Acetate

(1) Internal

(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Palmitate

(1) Internal

(1) Equivalent to 7,500iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Warfarin

Warfarin Sodium

Xamoterol Fumarate

Xipamide

Yohimbine Hydrochloride

F22Zalcitabine

Zidovudine

Zimeldine Hydrochloride

Zolpidem Tartrate

Zomepirac Sodium

Zopiclone

Zuclopenthixol Acetate

Zuclopenthixol Decanoate

Zuclopenthixol Hydrochloride

F97SCHEDULE 2SUBSTANCES WHICH MAY BE EXCLUDED FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES AT HIGH DILUTION

Article 10(1)

  • Codeine and its salts

  • Dihydrocodeine and its salts

  • Ethylmorphine and its salts

  • Morphine and its salts

  • Medicinal Opium

  • Pholcodine and its salts

F98SCHEDULE 3DESCRIPTIONS AND CLASSES OF PRESCRIPTION ONLY MEDICINES IN RELATION TO WHICH community practitioner nurse prescribers ARE APPROPRIATE PRACTITIONERS

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F98SCHEDULE 3ACONTROLLED DRUGS WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY NURSE INDEPENDENT PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

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F98SCHEDULE 3BPARTICULARS FOR CLINICAL MANAGEMENT PLANS

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F98SCHEDULE 4SUBSTANCES NOT TO BE CONTAINED IN A PRESCRIPTION ONLY MEDICINE SOLD OR SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(3)

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F98SCHEDULE 5EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

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F98SCHEDULE 6ORDERS REVOKED

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F98SCHEDULE 7

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(This note is not part of the Order)

This Order consolidates with amendments the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 as amended. That Order and the Orders amending it (“the 1983 Order as amended”) are revoked by article 16 and Schedule 6.

This Order specifies the descriptions and classes of prescription only medicines (i.e. medicinal products which, subject to exemptions, may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner). Many medicinal products are included in a class of such medicines by reason of the substances contained in them (seeSchedule 1) but others are included because of other criteria, such as their method of administration (seearticle 3). In many cases the provisions of the Act apply subject to exemptions (seearticles 4 and 5 to 13 and Schedule 1).

The principal amendments relate to those medicines in respect of which marketing authorizations have been granted by the European Community. They include as prescription only medicines those medicines in respect of which such an authorization has been granted which classifies a medicine as being subject to medical prescription (article 3(f)). They exclude from the class of prescription only medicines those medicines in respect of which such an authorization provides for supply which is not subject to medical prescription (article 6(3)).

The differences between this Order and the 1983 Order as amended are in the main technical changes concerning the location of provisions such as the division of material in Schedule 1 to the 1983 Order as amended between the new Schedules 1 and 2. But within the new Schedule 1 there are changes which relate to–

(a)

the deletion from Column 1 of substances which are no longer used in those medicinal products which are on the market;

(b)

the use of current names for the substances which are specified in that Column where their names have changed;

(c)

the incorporation in that Schedule of provisions from article 4 of, and Part IV of Schedule 1 to, the 1983 Order as amended so that they may be found more easily;

(d)

a change in the legal base for the entries in Columns 2 to 4 so that those entries now form the criteria for exemptions from the sale or supply requirements of section 58(2) of the Medicines Act 1968 instead of the criteria for excluding medicinal products from the class of prescription only medicines (see alsoarticle 5);

(e)

the introduction of a fifth Column which specifies the maximum pack sizes to which exemptions apply.

As this order will impose no additional costs to business a compliance cost assessment has not been prepared.