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Update on Position Paper on Availability, February 2000

Update on Position Paper on Availability, February 2000

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 These were: narcobarbital, , thiopental, (had to be withdrawn later, as no product containing the substance has ever been licensed for food producing animals), etorphine/diprenophine, propionylpromazine, acepromazine, , , 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, poultry Antiparasitics 2-Ethyl-1,3- Mastitis prevention Cattle No rec. There are several drugs available hexanediol against mastitis Insect repellent Cattle, horses Polyethylene glycol-7-glyceryl cocoate Annex II all food producing species Bromopropylate Diagnosis and treatment Honey bees Withdrawn Flumethrin Annex II honey bees of acariasis (Varroa Tau fluvalinate Annex II honey bees jacobsoni, Acarapis Annex I honey bees woodi) Cymiazole Annex III bees Coumafos Annex III bees Carbaril Treatment and control of No Withdrawn Alternatives are available ectoparasitoses information

Public EMEA/CVMP/130/00-FINAL 09 February 2000 5/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Treatment of helmin- Pigs, horses Withdrawn Annex I bovine, ovine, caprine, porcine thoses and control of Annex III porcine internal and external Annex I bovine, ovine, porcine, equidae parasites Doramectin Annex I bovine, ovine, porcine Levamisole Annex I bovine, ovine, porcine, poultry Fenbendazole Annex I bovine, ovine, porcine, equidae (Other benzimidazoles) 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 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 Heptenophos Treatment of infestations Cattle, pigs, Withdrawn Flumethrin Annex I bovine by mange mites horses, laying Annex III bovine hens Phoxim Annex III porcine Moxidectin Annex I bovine, ovine; Annex I equidae Ivermectin Annex I bovine, porcine, equidae Abamectin Annex I bovine; Annex III ovine Doramectin Annex I bovine, porcine Eprinomectin Annex I bovine Amitraz Annex I bovine, porcine Annex III bovine, ovine, caprine, chicken, salmonidae

Public EMEA/CVMP/130/00-FINAL 09 February 2000 6/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Treatment and control of Cattle, horse No rec. Diazinon Annex I bovine, porcine, ovine, caprine endo- and ectoparasites Amitraz Annex I bovine, ovine, porcine Flumethrin Annex I bovine Moxidectin Annex I bovine, ovine; Annex I equidae Ivermectin Annex I equidae, bovine, porcine, ovine Doramectin Annex I bovine, ovine, porcine Eprinomectin Annex I bovine Abamectin Annex I bovine; Annex III ovine Cypermethrin Annex III bovine, ovine, caprine, porcine, chicken, salmonidae Phoxim Annex III porcine It is used as a larvicide for Cattle, pigs, Withdrawn Cyfluthrin Annex III bovine animals to prevent horn, horses 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 Agents acting on the autonomic nervous system Camylofine Treatment of visceral Cattle, sheep, Withdrawn Atropine Annex II all food producing species spasms pigs, horses Ephedrine Treatment of respiratory Cattle, sheep, No rec. Epinephrine (as cardiac analeptic) Annex II all food producing species and cardiac disorders goats, pigs, Doxapram (as respiratory analeptic) Annex II all mammalian food producing horses species Antihistamines Treatment of pharyngitis, Cattle, sheep, No rec. Chlorphenamine Annex II all mammalian food producing laryngitis, tracheitis, goats, pigs, species bronchitis, bronchial horses spasm, enteral spasmolysis, urticaria, serum shock, laminitis, and for the symptomatic relief of pain and swelling

Public EMEA/CVMP/130/00-FINAL 09 February 2000 7/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Agents acting on the central nervous system Acepromazine Sedation, neurolept- Cattle, sheep, No rec. No alternatives analgesia goats, pigs, horses Ammonium Treatment of acute Cattle (calves) Withdrawn Doxapram Annex II all mammalian food producing phthalamate respiratory disorders of species new-born calves Prethcamide Annex II all food producing mammalian species Amperozide Treatment and reduction Pigs Withdrawn Azaperone Annex I porcine hydrochloride of aggressiveness and stress Benzetimide Treatment of diarrhoea Cattle, sheep, No rec. Butylscopolaminium Annex II all food producing species hydrochloride pigs hydrate General anaesthesia Cattle, pigs, Withdrawn in combination with Annex II all food producing mammalian horses species hydrochloride Annex II bovine, equidae General anaesthesia No Annex IV Not of importance information Annex II equidae Chlorpromazine Sedation Cattle, sheep, Annex IV No alternatives goats, pigs, horses, Dextrometorphan Treatment of cough Cattle, sheep, Withdrawn Butorphanol (different mode of action) Annex II equidae hydrobromide goats, pigs, Not of importance horses Diazepam Anxiety related Cattle, sheep, No rec. No alternatives behavioural problems and goats, pigs, animal aggressiveness. horses, (Alternatives with other mode of Treatment of convulsions poultry, action, e.g. , but no MRL) in hypoxic neonatal donkey animals Narcobarbital General anaesthesia Pigs Withdrawn No alternatives

Public EMEA/CVMP/130/00-FINAL 09 February 2000 8/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Opium tincture Treatment of diarrhoea Cattle No rec. Bismuth compounds Annex II all food producing species

Pentetrazol Treatment of acute Cattle, sheep, Withdrawn Doxapram Annex II all mammalian food producing respiratory disorders of pigs, horses species new-born animals Prethcamide Annex II all food producing mammalian species Pentoxyverine Treatment of cough Horses No rec. Butorphanol (different mode of action) Annex II equidae Propionylpromazine Sedation and Cattle, pigs, No rec. No alternatives premedication of narcosis horses Muscle relaxants Guaifenesin Muscle relaxation Horse Withdrawn No alternatives Local anaesthetics Butanilicaine Local anaesthetic No No rec. Lidocain Annex II equidae (for local-regional information on anaesthesia only) target species Mepivacaine Annex II equidae (for intra-articular and epidural use as anaesthetic only)) (Tetracaine) Annex II all food producing species (Procaine) Annex II all food producing species Agents acting on the reproductive system Fenprostalene Synchronisation of Cattle, pigs Withdrawn Dinoprost Annex II all mammalian species (prostaglandin and oestrus, reproductive Dinoprost tromethamine Annex II all mammalian species analogues) disorders associated with Cloprostenol Annex II bovine, porcine, equidae persistent corpus luteum, R-Cloprostenol Annex II bovine, porcine, equidae termination of unwanted Tiaprost Annex II bovine, ovine, porcine, equidae pregnancies (cattle), Etiproston tromethamine Annex II bovine, porcine induction of parturation Luprostiol Annex II all mammalian species (cattle, pigs) Androgen therapy Cattle, pigs, Withdrawn Not of importance horses Antiinflammatory agents Diclofenac The non-steroidal anti- Cattle, pigs No rec. Ketoprofen Annex II bovine, porcine, equidae inflammatory drug Annex I bovine, porcine

Public EMEA/CVMP/130/00-FINAL 09 February 2000 9/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Treatment of non- Cattle No rec. See phenylbutazone infective arthritis, pneumopathies and mastitis. Phenazone Analgesic, antipyretic, Cattle, sheep, No rec. See phenylbutazone spasmolytic pigs, horses

Excipient in a product Cattle, sheep against trypanosomiasis and babesiosis Phenylbutazone Treatment of Cattle, pigs, No rec. Vedaprofen Annex I equidae inflammatory conditions horses Flunixin Annex I bovine, porcine of the musculoskeletal/ Tolfenamic acid Annex I bovine, porcine locomotor system Acetylsalicylic acid Annex II bovine, porcine, poultry Ketoprofen Annex II bovine, porcine, equidae Meloxicam Annex I bovine Populeum ointment Local treatment of Cattle, sheep, No rec. Several parenteral drugs and herbal inflammations goats, pigs, remedies for topical application are horses available Ramifenazone Treatment of Cattle, pigs, No rec. See phenylbutazone inflammatory conditions horses of the musculoskeletal/ locomotor system Suxibuzone Treatment of Cattle, sheep, No rec. See phenylbutazone inflammatory conditions pigs, horses of the musculoskeletal/ locomotor system Corticosteroids Dexamethasone -21- Treatment of metabolic Cattle, pigs, Withdrawn Dexamethasone Annex I bovine, porcine, equidae (3- sulfobenzoate) diseases (e.g. ketosis) in horses Hydrocortisone Annex II all food producing species ruminants and inflammatory diseases in a number of animal species Public EMEA/CVMP/130/00-FINAL 09 February 2000 10/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Flumethasone Treatment of Cattle, sheep, Withdrawn Dexamethasone Annex I bovine, porcine, equidae inflammatory diseases, goats, pigs, Hydrocortisone Annex II all food producing animals ketosis in ruminants, horse Prednisolone Annex I bovine shock and allergic Betamethasone Annex I bovine, porcine diseases Methylprednisolone Annex III bovine Isoflupredone Treatment of a number of Cattle No rec. Dexamethasone Annex I bovine, porcine, equidae conditions including Hydrocortisone Annex II all food producing species bovine ketosis, shock and allergic reactions Prednisolone -21- (3- Treatment of bovine Cattle, sheep, Withdrawn Prednisolone Annex I bovine sulfobenzoate) mastitis goats, pigs, Dexamethasone Annex I bovine, porcine, equidae horses Hydrocortisone Annex II all food producing species Prednisolone 21- Treatment of mastitis Cattle, sheep, Withdrawn Prednisolone Annex I bovine acetate goats, pigs, Dexamethasone Annex I bovine, porcine, equidae horses Hydrocortisone Annex II all food producing species Agents acting on the gastrointestinal system Benzonaphtol Treatment of diarrhoea Cattle, sheep, Withdrawn Not relevant (not used) goats, pigs, horses Clanobutin Indigestion, atony, Cattle, sheep, Withdrawn Menbutone (different mode of action) Annex II bovine, ovine, caprine, porcine, insufficient food goats, pigs equidae consumption, obstipation and protective therapy for the liver Halquinol Treatment of diarrhoea Pigs, poultry Withdrawn Flumequine Annex I bovine, ovine, porcine, chicken, (microbial origin) salmonidae Topical agents Benzyl nicotinate Local treatment of No Withdrawn Not of importance inflammatory conditions information (rubifacient) Benzylideneacetone Treatment of respiratory, Cattle, horses No rec. Not of importance vascular and rheumatoid disorders

Public EMEA/CVMP/130/00-FINAL 09 February 2000 11/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Colchicine Treatment of papillomas Cattle, horses Annex IV Concentrated lactic acid Annex II all food producing species and warts Other alternative therapies are auto- vaccination and cryosurgery Copper naphthenate Treatment of foot rot Cattle, sheep Withdrawn Copper sulphate Annex II all food producing species Peracetic acid Annex II all food producing species

Treatment of ringworm See griseofulvin Polyhexanide Disinfectant for Cattle Withdrawn Sodium chlorite Annex II bovine prevention of teats Sodium dichloroisocyanurate Annex II bovine, ovine, caprine infection Chlorhexidine Annex II all food producing species Iodophors Annex II all food producing species Miscellaneous Ammonium Treatment of copper Sheep Withdrawn Calcium disodium EDTA Annex II all food producing animals molybdate poisoning (Ethylenediaminetetraacetic acid and salts) Copper 8-hydroxy- Treatment or prevention Pigs, poultry Withdrawn There are several drugs available quinoline of infectious gastro- against Gram positive and Gram intestinal diseases (against negative bacteria a wide range of Gram positive and Gram negative bacteria) Diethylamine copper Treatment of copper Cattle, sheep Withdrawn Copper sulphate Annex II all food producing species oxyquinolone insufficiency Copper oxide Annex II all food producing species sulphonate Copper heptonate Annex II all food producing species (cuproxoline) Metesculetol sodium Vascular diseases Horses No Rec. Hesperidin Annex II equidae (Permethol) Hesperidin methyl chalcone Annex II equidae Phenylethyl Treatment of bacterial Cattle, sheep, Withdrawn Alternatives are available infections (active against pigs Gram-negative bacteria) Thenoic acid Treatment of cough and Cattle, sheep, Withdrawn Dembrexine Annex II equidae respiratory disease pigs, horses Bromhexine Annex II bovine, porcine, poultry (expectorant) Ammonium chloride Annex II all food producing animals

Public EMEA/CVMP/130/00-FINAL 09 February 2000 12/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Chelidonii herba Treatment of digestive Cattle (except No rec. Lini oleum Annex II all food producing species disorders, disturbances of lactating Quercus cortex Annex II all food producing species intestinal microflora, cows), pigs, Sodium 2-methyl-2-phenoxy- Annex II bovine, caprine, porcine, equidae chronic gastritis, enteritis, horses propanoate coprophagy, metabolic Tanninum Annex II all food producing species disorders, lack of appetite Niauli oil Treatment of mild upper- Cattle No rec. Alternatives are available respiratory tract infections Pini extraxtum Secretolytic for treatment Cattle, sheep, Withdrawn Bromhexine Annex II bovine, porcine, poultry of bronchitis pigs, horses Dembrexine Annex II equidae Rhamni purshiani Treatment of constipation All food- No rec. Aloe vera gel and whole leaf extract of Annex II all food producing species cortex producing Aloe vera species Secalis cornuti Treatment of Cattle, sheep, No rec. Alternatives are available extractum endometritis, retained goats, pigs, placenta, atonia of uterus, horses prolapsus uteri, uterine bleeding and for heart and blood circulatory problems around parturition Apis mellifera All food- No rec. Alternatives are available (veterinary producing homeopathy) species Aristolochia spp. and Regulation of sexual Cattle, sheep, Annex IV Alternatives are available preparations thereof functions, goats, pigs, (veterinary immunostimulation, horses homeopathy) antiphlogistic effects and other indications Berberis vulgaris All food- No rec. Alternatives are available (veterinary producing homeopathy) species Bryonia All food- No rec. Alternatives are available (veterinary producing homeopathy) species Public EMEA/CVMP/130/00-FINAL 09 February 2000 13/16 ãEMEA 2000 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Chelidonium majus All food- No rec. Alternatives are available (veterinary producing homeopathy) species Collinsonia All food- No rec. Alternatives are available canadensis producing (veterinary species homeopathy) Drosera All food- No rec. Alternatives are available (veterinary producing homeopathy) species Lophophytum leandri All food- No rec. Alternatives are available (veterinary producing homeopathy) species Oenanthe aquatica It is used as an expecto- All food- No rec. Alternatives are available (veterinary rant and antitussive agent producing homeopathy) for treatment of chronic species respiratory tract diseases and for treatment of gastrointestinal disorders Viburnum opulus All food- No rec. Alternatives are available (veterinary producing homeopathy) species Viburnum All food- No rec. Alternatives are available prunifolium producing (veterinary species homeopathy) Excipients Glycofurol Excipient used in Cattle, pigs Withdrawn Excipients not considered at present injectable solutions Polyethylene Excipient No Withdrawn Excipients not considered at present terephthalates information

Public EMEA/CVMP/130/00-FINAL 09 February 2000 14/16 ãEMEA 2000 Annex 2 Substances, which are not available for veterinary medicines, and where no MRL application has been made (non-defended substances)

Substances previously authorised for veterinary medicines

Substances Indication Species3 Examples for alternatives MRL Status for these alternatives4 Anti-infectious agents 2-Hydroxy-propyl-tri- Treatment of actinomycosis Cattle, sheep Iodine salts Annex II all food producing species ammonium iodide (Penicillins) Annex I all food producing species Nalidixic acid Treatment of urinary tract Cattle, pigs, rabbits, Enrofloxacin Annex I bovine, porcine, poultry, rabbits infections and septicaemia chicken, turkey Danofloxacin Annex I porcine Broad spectrum penicillins: Amoxicillin Annex I all food producing species Antimycotics Griseofulvin Treatment of fungal diseases, Cattle, horses Natamycin (for topical use only) Annex II bovine, equidae treatment of dermatophytoses Enilconazole (for topical use only) Annex II bovine, equidae Antiparasitic agents Pyrimethamine Treatment of coccidiosis and Rabbits Sulfonamides (sulphaquinoxaline) Annex I all food producing species, but bacterial infections only used in combination products with diaminopyrimidines/trimethoprim Agents acting on the central nervous system Fluanisone + Neuroleptanalgesia Rabbits Only used for pets and laboratory animals, i.e. not relevant for food producing animals Inhalation anaesthetic for Cattle, sheep, goats, pigs, Isoflurane Annex II equidae general anaesthesia horses, donkey Xylazine hydrochloride (different Annex II bovine, equidae application route) Comment: as far as known halothane is used only for horses, companion animals and laboratory animals. Not used as anaesthesia for pigs.

3 Species, indicated by Member States 4 CVMP recommendations not yet published in the OJ are written in italics Public EMEA/CVMP/130/00-FINAL 09 February 2000 15/16 ãEMEA 2000 Substances Indication Species3 Examples for alternatives MRL Status for these alternatives4 Metomidate Sedation Pigs No alternatives (Alternatives with other mode of action, e.g. barbiturates, but no MRL) Nikethamide Respiratory stimulant for Cattle, pigs, horses, donkey Doxapram Annex II all mammalian food producing treatment of acute respiratory species disorders Prethcamide Annex II all food producing mammalian species Pethidine Analgesia Horses, donkey Butorphanol tartrate Annex II equidae Agents acting on the autonomic nervous system Adiphenine Parasympatholytic for Cattle, sheep, goats, pigs, Atropine Annex II all food producing species hydrochloride treatment of colics and horses, donkey Atropa belladonna Annex II all food producing species spasmodic syndromes Butylscopolaminium bromide Annex II all food producing species Carbachol Parasympathomimetic for Cattle, pigs, horses, donkey Neostigmine Annex II all food producing species treatment of atony of gastrointestinal tract, urinary bladder and uterus. Treatment of ruminal atony and impaction Etorphine Neuroleptanalgesia Cattle No alternatives Prifinium bromide Parasympatholytic for Cattle, horses, donkey Atropine Annex II all food producing species treatment of gastro-intestinal Atropa belladonna Annex II all food producing species and urinal tract spasms Butylscopolaminium bromide Annex II all food producing species Sinefrene Treatment of shock, cardiac Cattle, pigs Epinephrine Annex II all food producing species syncope and anaphylactic Ergometrine maleate Annex II All mammalian food producing emergencies species Yohimbine Reversal of effects of a2 - Cattle, deer No alternatives antagonist, e.g. Xylazine Miscellaneous Aminopromazine Spasmolytic for treatment of Cattle, sheep, pigs, horses, Isoxsuprine Annex II bovine, equidae gastro-intestinal, bronchial and donkey Butylscopolaminium bromide Annex II all food producing species genito-urinary tract spasms Clenbuterol Annex III bovine, equidae According to the indications there are several different drugs available

Public EMEA/CVMP/130/00-FINAL 09 February 2000 16/16 ãEMEA 2000

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