The Pharmaceutical Journal
Vol 271 No 7278 p797
6 December 2003
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The Pharmaceutical Journal |
| Society summary |
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). |
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). |
Human medicines |
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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 Emtriva capsules POM FemTab POM FemTab Sequi POM FemTab Continuous POM Forsteo injection POM Fuzeon injection POM Gammahydroxy-butyrate [GHB] CD benz 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
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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 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 Zamadol Melt tablets POM Zispin SolTabs POM Zolpidem tartrate entry should read: Zolpidem tartrate CD Benz POM |
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