In the first issue of each month, The
Journal updates the guidance on the legal status of medicines published in the
27th edition (July 2003) of ‘Medicines, ethics and practice: A
guide for pharmacists’.
The amendments are given in
bold type when added to the list and repeated each month in light type.
A product’s legal status can be
obtained by consulting first the
latest amendment list and then the guide. The abbreviations used in the
list are explained in the key to annotations in the body of the guide (p29
and p75).
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Users of the guide should note that changes
to the reclassification procedure for medicines mean that the legal status
of a product now becomes part of its marketing authorisation rather than
being determined by the active substance listed in secondary legislation.
Because a change of legal status will be conferred only on products that
are the subject of an application for reclassification, users of the
guide should refer to the entry for the specific proprietary product
and not rely only on the entry for the active substance. Since the POM
Order remains in force, entries for active substances will remain in
the guidance but will include cross references wherever proprietary products
have been reclassified. Further guidance or clarification on the status
of individual products can be obtained from manufacturers or from the
Medicines and Healthcare products Regulatory Agency (tel 020 7273 0523;
e-mail info@mhra.gsi.gov.uk). |
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Alka Rapid crystals GSL
Alomide Allergy ophthalmic solution P
Anthisan Bite and Sting cream GSL
Anthisan Plus spray entry should read: Anthisan Plus spray GSL
4-Androstene-3,17-dione CD Anab POM
5-Androstene-3,17-diol CD Anab POM
Avandamet tablets POM
Beclometasone/ Beclomethasone dipropionate entry — replace "P" at
end of entry with "please refer to proprietary names for classification
granted under the marketing authorisation (see Beconase products)"
Beconase Allergy nasal spray entry should read: Beconase Allergy nasal
spray P
Beconase Hayfever nasal spray entry should read: Beconase Hayfever nasal
spray GSL
Canesten AF Once Daily P
Canesten Complete P
Cetraben emollient bath additive GSL
Cetraben emollient cream GSL
Co-codamol eff entry should read: Co-codamol 8/500 effervescent CD Inv
P
Co-codamol entry should read: Co-codamol 8/500 pack sizes 32s CD Inv
P; greater than 32s CD Inv POM
Co-codamol 30/500 preparations CD Inv POM
Dihydroetorpine CD POM
Duac Once Daily Gel POM
Emend capsules POM
Emtriva capsules POM
FemTab POM
FemTab Sequi POM
FemTab Continuous POM
Forsteo injection POM
Fuzeon injection POM
Gammahydroxy-butyrate [GHB] CD benz POM
Gonapeptyl Depot POM
Humira injection POM
4-Hydroxy-n-butyric acid CD Benz POM
InductOs POM
Keloc SR tablets POM
Ketoconazole entry — replace "P" at end of entry with "please
refer to proprietary names for classification granted under the marketing
authorisation (see Nizoral products)"
Lemsip Flu 12Hr P
Lemsip Max Cold and Flu Direct GSL |
Metvix cream POM
Minijet Morphine CD POM
Minoxidil entry — delete first "P" and replace "P" at
end of entry with "please refer to proprietary names for classification
granted under the marketing authorisation (see Regaine products)"
Modisal preparations entry should read: Modisal XL tablets P
Monit tablets entry should read: Monit tablets P
Monit SR tablets entry should read: Monit SR tablets P
Monit XL tablets P
Morphine (Minijet) CD POM
Motilium preparations entry should read: Motilium suppositories POM
Motilium suspension POM
Motilium tablets POM
Motilium 10 tablets P
Niaspan tablets POM
Nicotinell liquorice coated gum GSL
Nicotinell extra strength mint lozenges GSL
Nicotinell TTS entry should read: Nicotinell TTS GSL
NiQuitin CQ mint lozenges GSL
Nizoral (Johnson & Johnson MSD) Anti Dandruff shampoo GSL
19-Nor-4-androstene-3,17-dione CD Anab POM
19-Nor-5-androstene-3,17-diol CD Anab POM
Olmetec tablets POM
Panadol Actifact tablets pack size 14 GSL
Presinex nasal spray POM
Regaine topical solution entry should read: Regaine Regular Strength topical
solution GSL
Relestat eye-drops POM
Remifentanil CD POM
Salicylic acid entry — delete maximum strengths in sections 2 (corn plasters)
and 10 (wart plasters)
Stalevo tablets POM
Stilnoct tablets entry should read: Stilnoct tablets CD Benz POM
Subcuvia injection POM
Sudafed Congestion Relief capsules, non-drowsy GSL
Testogel gel CD Anab POM
Tixyplus suspension P
Ultiva entry should read: Ultiva injection CD POM
Veno’s for Kids GSL
Ventavis POM
Zamadol Melt tablets POM
Zispin SolTabs POM
Zolpidem tartrate entry should read: Zolpidem tartrate CD Benz POM
Zyprexa IntraMuscular POM
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