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Position Paper on Availability of Veterinary Medicines Agreed on 14 October 1999

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Position Paper on Availability of Veterinary Medicines Agreed on 14 October 1999 The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/CVMP/731/99-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS Update of the Position Paper on Availability of Veterinary Medicines agreed on 14 October 1999 At the meeting on 16-18 March 1999 the CVMP adopted the Position Paper on Availability of Veterinary Medicines (EMEA/CVMP/151/99-FINAL), which identified from the lists of substances no longer available 10 substances as essential. These were: narcobarbital, thiamylal, thiopental, pentobarbital (had to be withdrawn later, as no product containing the substance has ever been licensed for food producing animals), etorphine/diprenophine, propionylpromazine, acepromazine, metomidate, diazepam, yohimbine. Following further scrutiny of the substances recently evaluated, for which no MRLs can be established, the list of substances considered essential in veterinary medicine was updated at the meeting on 12-14 October. The substances and indications identified as essential as per October 1999 are: 1. Indication: general anaesthesia by injection Substances: · Narcobarbital (pigs), Thiamylal (cattle, sheep, goats, horses, pigs), Thiopental sodium (cattle, goats, horses, pigs, rabbits, birds); 1 · Etorphine/Diprenophine (cattle) 2. Indication: neuroleptic analgesia, sedation and premedication of narcosis Substances: Propionylpromazine (cattle, horses, pigs), Acepromazine (cattle, sheep, goats, horses, pigs) 3. Indication: sedation Substances: Metomidate (pigs) 1 4. Indication: anxiolysis, tranquilisation Substance: Diazepam (cattle, sheep, goats, horses, donkeys, pigs, poultry and game birds) 1 5. Indication: Antagonism of a2-adrenergic effects Substance: Yohimbine (cattle, deer) 1 6. Indication: nosemosis in honey bees, proliferative kidney disease in trout. Substances: Fumagillin It should be noted that this list is still considered as a draft and can possibly only be finalised once the procedures of all MRL applications for old substances have been closed. The lists of substances which served as working documents for the CVMP in its attempts to identify those products which are essential in veterinary medicine today are attached to this document (Annexes 1 to 2). Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Switchboard (44-20-7) 418 8400 Fax (44-20-7) 418 8447 E-mail: [email protected] http://www.eudra.org/emea.html ãEMEA 1999 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Since March 1999 the CVMP undertook efforts to salvage the essential substances identified and to obtain further data possibly available in the public domain or within institutions outside the EU, which have not been included in the dossier or the assessment in order to set MRLs. While any possible effort was made it appears at present that these attempts will possibly only allow salvaging one or two of the essential substances. Particularly in respect to the substances never defended the information available in public domain is not promising. 14 October 1999 2/16 ãEMEA 1999 Annex 1 Substances, which are no longer available in veterinary medicines Substances considered under Article 7 of Regulation 2377/90 (defended substances) (MRL applications withdrawn, no recommendation for inclusion in Annex I, II or III possible, included in Annex IV) Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Antibacterials and antiprotozoals Cefuroxime Treatment of clinical Cattle No rec. There are several drugs available mastitis in lactating cattle against mastitis and treatment of sub- clinical infections and reduction of the risk of new infections in dry cattle Chloramphenicol Treatment of bacterial Cattle (calves), Annex IV Thiamphenicol Annex I bovine, chicken infections (against broad- pigs, poultry Florfenicol Annex I bovine spectrum of bacteria) Amoxicillin Annex I all food producing species Dapsone Coccidiosis Cattle Annex IV Sulfonamides Annex I all food producing species Treatment of mastitis and There are several drugs available endometritis against mastitis and endometritis Furazolidone Coccidiosis Cattle Annex IV (see Dapsone) Pigs Sulfonamides (sulphaquinoxaline) Annex I all food producing species Rabbits Sulfonamides (sulphaquinoxaline) Annex I all food producing species Poultry Amprolium List of questions (chicken, turkey) Toltrazuril Annex I chicken, turkey Sulfonamides Annex I all food producing species Treatment of bacterial Fish Sarafloxacin Annex I salmonidae infections (against Gram Flumequine Annex I salmonidae positive and Gram negative bacteria) 1 Species, for which MRL application was made; also species for which products are authorised in the EU, as far as information available and was included in Summary Report 2 CVMP recommendations not yet published in the OJ are written in italics 14 October 1999 3/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Nitrofurans (except Treatment of bacterial All food Annex IV There are several drugs available Furazolidone) infections (against Gram producing against infection of Gram positive and positive and Gram species Gram negative bacteria negative bacteria) Treatment of protozoal Imidocarb Annex III bovine, ovine diseases Toltrazuril Annex I chicken, turkey Dimetridazole Genital trichomoniasis Cattle Annex IV No alternatives Haemorrhagic enteritis Pigs Histomoniasis Turkeys Trichomoniasis Pigeons Metronidazol Retentio secundinarium Cattle Annex IV Not of importance (in combination with neomycin) Dysentery (Serpulina Pigs Tiamulin Annex I porcine, chicken hyodysenteriae), Lincomycin Annex III porcine Valnemulin Annex III porcine Ronidazole Genital trichomoniasis Cattle Annex IV No alternatives Haemorrhagic enteritis Pigs Histomoniasis Turkeys Trichomoniasis Pigeons Antimycotics Nystatin Treatment of ringworm Cattle, horses Withdrawn Natamycin (for topical use only) Annex II bovine, equidae Enilconazole (for topical use only) Annex II bovine, equidae Treatment of candidiasis Poultry Not of importance Anthelmintics Thiophanate Treatment of Cattle, sheep, Withdrawn Febantel Annex I bovine, ovine, porcine, equidae helminthoses goats, pigs Fenbendazole Annex I bovine, ovine, porcine, equidae Albendazole Annex I bovine, ovine Levamisole Annex I bovine, ovine, porcine, poultry 14 October 1999 4/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Bithionol sulfoxide Treatment of Cattle, sheep Withdrawn Closantel Annex I bovine, ovine helminthoses (against Triclabendazole Annex I bovine, ovine adult Fasciola hepatica Nitroxinil Annex I bovine, ovine and Paramphistomum spp) Oxyclosanide Annex III bovine, ovine Niclosamide Treatment of Sheep Withdrawn Praziquantel (as niclosamide also Annex II ovine, equidae helminthoses praziquantel is effective against Taenia and Echinococcus) Chicken Not relevant for chicken; due to modern husbandry practice disease very rare Antiparasitics Bromopropylate Diagnosis and treatment Honey bees Withdrawn Flumethrin Annex II honey bees of acariasis (Varroa Tau fluvalinate Annex II honey bees jacobsoni, Acarapis Amitraz Annex III bees woodi) Cymiazole Annex III honey bees Coumaphos Annex III honey bees Fenthion Treatment and control of Cattle, pigs Withdrawn Diazinon Annex I bovine, ovine, caprine, porcine ectoparasitoses and Amitraz Annex I bovine, ovine, porcine hypodermiasis in cattle Flumethrin Annex I bovine Phoxim Annex III porcine Phosmet List of questions (bovine, porcine) Moxidectin Annex I bovine, ovine; Annex III equidae Ivermectin Annex I bovine, ovine, porcine, equidae Doramectin Annex I bovine, ovine, porcine Eprinomectin Annex I bovine Abamectin Annex I bovine Fumagillin Treatment and prevention Honey bees No rec. No alternatives of nosemosis Prevention and treatment Trout of proliferative kidney disease 14 October 1999 5/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Heptenophos Treatment of infestations Cattle, pigs, Withdrawn Flumethrin Annex I bovine by mange mites horses, laying Cyfluthrin Annex III bovine hens Phoxim Annex III porcine Moxidectin Annex I bovine; Annex III equidae Ivermectin Annex I bovine, porcine, equidae Abamectin Annex I bovine Doramectin Annex I bovine, porcine Eprinomectin Annex I bovine Amitraz Annex I bovine, porcine Cypermethrin Annex III bovine, ovine, caprine, chicken, salmonidae List of questions (eggs) Dichlorvos Treatment of helmin- Pigs, horses Withdrawn Phosmet List of questions (bovine, porcine) thoses and control of Diazinon Annex I bovine, ovine, caprine, porcine internal and external Phoxim Annex III porcine parasites Ivermectin Annex I bovine, ovine, porcine, equidae Doramectin Annex I bovine, ovine, porcine Levamisole Annex I bovine, ovine, porcine, poultry Fenbendazole Annex I bovine, ovine, porcine, equidae (Other benzimidazoles) Tetrachlorvinphos It is used as a larvicide for Cattle, pigs, Withdrawn Cyfluthrin Annex III bovine animals to prevent horn, horses Permethrin Annex III bovine, ovine, porcine face, house and stable Cypermethrin Annex III bovine, ovine, caprine, porcine, flies chicken, salmonidae Eprinomectin Annex I bovine Moxidectin Annex I bovine, ovine; Annex III equidae 2-Ethyl-1,3- Mastitis prevention Cattle No rec. There are several drugs available hexanediol against mastitis Insect repellent Cattle, horses Polyethylene
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