The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/CVMP/130/00-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS Update of the Position Paper on Availability of Veterinary Medicines agreed on 9 February 2000 The Committee for Veterinary Medicinal Products (CVMP) adopted at its meeting on 16-18 March 1999 a Position Paper on Availability of Veterinary Medicines (EMEA/CVMP/151/99- FINAL), presenting recommendations in respect of the problem that insufficient medicinal products are available for the treatment of certain diseases and certain animal species. In this document the CVMP also identified from the lists of substances no longer available, 10 substances as being 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 These were: narcobarbital, thiamylal, thiopental, pentobarbital (had to be withdrawn later, as no product containing the substance has ever been licensed for food producing animals), etorphine/diprenophine, propionylpromazine, acepromazine,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. Subsequent to further scrutiny of the substances evaluated in the following 6 months, for which no MRLs could be established, the list of substances considered essential in veterinary medicine was updated at the meeting on 12-14 October (EMEA/CVMP/731/99-FINAL) to include also fumagillin. At the meeting on 7-9 December 1999 the CVMP added guaifenesin to this list. Having reached the deadline of 31 December 1999 by which MRLs had to be set for old defended substances, the CVMP then undertook the review of those substances evaluated since October 1999, for which no MRLs could be established, particularly considering the outstanding substances, for which no response to the list of questions was submitted by the applicants. The Committee then further updated the list of substances considered essential at the meeting on 8-10 February 2000. Since March 1999 the CVMP undertook additional efforts to salvage the essential substances identified and to obtain further data which might be available in the public domain, or within institutions outside the EU, which had not previously been included in the dossier or the assessment in order to set MRLs. Additional data were obtained which allowed the CVMP to recommend the inclusion of Thiopental sodium and Thiamylal in Annex II of Council Regulation (EEC) No. 2377/90. The CVMP however had to conclude that despite concerted efforts made to obtain further data, no recommendation to include narcobarbital, etorphine, diprenophine, propionylpromazine, acepromazine, diazepam, yohimbine or fumagillin in any of the annexes to Council Regulation (EEC) No. 2377/90 was possible. The remaining substances and indications identified as essential as per February 2000 are: 1. Indication: general anaesthesia by injection Substances: · Narcobarbital (pigs); 1 · Etorphine/Diprenophine (cattle) 2. Indication: neuroleptic analgesia, sedation and premedication of narcosis Substances: Propionylpromazine (cattle, horses, pigs), Acepromazine (cattle, sheep, goats, horses, pigs) 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 2000 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 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 (honey bees), proliferative kidney disease (trout) Substance: Fumagillin 7. Indication: Muscle relaxation (horses) Substance: Guafenisin 8. Indication: Trypanosomiasis (cattle, sheep, horses) Substance: Diminazene 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 and 2). It should be noted that this list might need to be updated again once the procedures of the remaining MRL applications for 3 old substances have been closed (1 substance for which the response to the list of questions was submitted only shortly before 31 December 1999 is still regarded as being “under evaluation”, and for 2 other substances going through an appeal procedure). Any enquiries regarding this document may be directed to the attention of Dr Kornelia Grein, Head of Sector (Safety of Veterinary Medicines) at the EMEA, 7 Westferry Circus, Canary Wharf, London E14 4HB, telephone +44 20 7 418 8432. Public EMEA/CVMP/130/00-FINAL 09 February 2000 2/16 ãEMEA 2000 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 Dimetridazole Genital trichomoniasis Cattle Annex IV No alternatives Haemorrhagic enteritis Pigs Histomoniasis Turkeys Trichomoniasis Pigeons Diminazene Treatment of Cattle, sheep, Withdrawn Imidocarb (against babesiosis) Annex III bovine, ovine trypanosomiasis and horses No alternatives against babesiosis trypanosomiasis 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 Public EMEA/CVMP/130/00-FINAL 09 February 2000 3/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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 Annex III chicken, turkey Treatment of bacterial Toltrazuril Annex I chicken, turkey; Annex III porcine infections (against Gram Sulfonamides Annex I all food producing species positive and Gram Fish Sarafloxacin Annex I salmonidae negative bacteria) Flumequine Annex I salmonidae Kitasamycin Treatment of diseases Pigs, poultry Withdrawn Erythromycin Annex I bovine, ovine, porcine, chicken caused by mycoplasmas Tylosin Annex I bovine, porcine, poultry and Gram-positive Spiramycin Annex I bovine, porcine, chicken bacteria, some Gram- negative bacteria, spirochetes and rickettsiae Metronidazol Retentio secundinarium Cattle Annex IV Not of importance (in combination with neomycin) Dysentery (Serpulina Pigs Tiamulin Annex I porcine, chicken; Annex III turkey hyodysenteriae), Lincomycin Annex III porcine, sheep, chicken; Annex I bovine Valnemulin Annex I porcine 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; Annex III porcine Ronidazole Genital trichomoniasis Cattle Annex IV No alternatives Haemorrhagic enteritis Pigs Histomoniasis Turkeys Trichomoniasis Pigeons Roxarsone Treatment of digestive Pigs, poultry No rec. Toltrazuril Annex I chicken, turkey; Annex III porcine disease due to coccidia or Amprolium hydrochloride Annex III chicken, turkey treponema Tiamulin Annex I porcine, chicken; Annex III turkey Public EMEA/CVMP/130/00-FINAL 09 February 2000 4/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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 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) Oxyclozanide 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 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,