Quick viewing(Text Mode)

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

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 These were: narcobarbital, , thiopental, (had to be withdrawn later, as no product containing the substance has ever been licensed for food producing animals), etorphine/diprenophine, propionylpromazine, acepromazine, , ,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. 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 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 glycol-7-glyceryl cocoate Annex II all food producing species Agents acting on the autonomic nervous system 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 Camylofine Treatment of visceral Cattle, sheep, Withdrawn Atropine Annex II all food producing species spasms pigs, horses

14 October 1999 6/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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 Agents acting on the central nervous system hydrate General anaesthesia Cattle, pigs, Withdrawn in combination with Annex II all food producing mammalian horses species hydrochloride Annex II bovine, equidae Narcobarbital General anaesthesia Pigs Withdrawn No alternatives Thiopental sodium General anaesthesia Cattle, goats, Withdrawn No alternatives pigs, horses, rabbits, birds Thiamylal General anaesthesia Cattle, sheep, No rec. No alternatives goats, pigs, horses General anaesthesia No Annex IV Not of importance information Annex II equidae Pentoxyverine Treatment of cough Horses No rec. Butorphanol (different mode of action) Annex II equidae Propionylpromazine Sedation and Cattle, pigs, Withdrawn No alternatives premedication of narcosis horses Acepromazine Sedation, neurolept- Cattle, sheep, Withdrawn No alternatives analgesia goats, pigs, horses 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, horses Not of importance

14 October 1999 7/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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 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 Opium tincture Treatment of diarrhoea Cattle No rec. Bismuth compounds Annex II all food producing species 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 Androgen therapy Cattle, pigs, Withdrawn Not of importance horses 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) Antiinflammatory agents Diclofenac The non-steroidal anti- Cattle, pigs No rec. Ketoprofen Annex II bovine, porcine, equidae inflammatory drug Annex I bovine, porcine

14 October 1999 8/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Methylprednisolone Treatment of Cattle, pigs, Withdrawn Prednisolone Annex I bovine inflammations of the horses Dexamethasone Annex I bovine, porcine, equidae musculo-skeletal system, Betamethasone Annex I bovine, porcine in combination with Flumethasone List of questions (cattle, sheep, goats, pigs, antibiotics: respiratory horses) diseases, urogenital infections 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 III bovine Treatment of non- Cattle No rec. See phenylbutazone infective arthritis, pneumopathies and mastitis. Suxibuzone Treatment of Cattle, sheep, No rec. See phenylbutazone inflammatory conditions pigs, horses of the musculoskeletal/ locomotor system Ramifenazone Treatment of Cattle, pigs, No rec. See phenylbutazone inflammatory conditions horses of the musculoskeletal/ locomotor system Phenazone Analgesic, antipyretic, Cattle, sheep, No rec. See phenylbutazone spasmolytic pigs, horses

Excipient in a product Cattle, sheep against trypanosomiasis and babesiosis Populeum ointment Local treatment of Cattle, sheep, No rec. Several parenteral drugs and herbal inflammations goats, pigs, remedies for topical application are horses available

14 October 1999 9/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Corticosteroids 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 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 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 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 III bovine, ovine, porcine, chicken (microbial origin) 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 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

14 October 1999 10/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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 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 Extraxtum pini Secretolytic for treatment Cattle, sheep, Bromhexine Annex II bovine, porcine, poultry of bronchitis pigs, horses Dembrexine Annex II equidae 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) Rhamni purshiani Treatment of constipation All food- No rec. Aloe Annex II all food producing species cortex producing species Oenanthe aquatica It is used as an All food- No rec. Alternatives are available expectorant and producing antitussive agent for species treatment of chronic respiratory tract diseases and for treatment of gastrointestinal disorders

14 October 1999 11/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 Rhei radix Treatment of hepatic Cattle No rec. Alternatives are available (veterinary dysfunction, hepatic (no longer homeopathy) congestion, and hepatitis used) of alimentary origin 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 Chelidonium majus All food- No rec. Alternatives are available (veterinary producing homeopathy) species Apis mellifera All food- No rec. Alternatives are available (veterinary producing homeopathy) species Collinsonia All food- No rec. Alternatives are available canadensis producing (veterinary species homeopathy) Lophophytum leandri All food- No rec. Alternatives are available (veterinary producing homeopathy) species Viburnum opulus All food- No rec. Alternatives are available (veterinary producing homeopathy) species Viburnum All food- No rec. Alternatives are available prunifolium (veteri- producing nary 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

14 October 1999 12/16 ãEMEA 1999 Substances Indication Species1 MRL Status Examples for alternatives MRL Status for these alternatives2 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

14 October 1999 13/16 ãEMEA 1999 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 Nalidixic acid Treatment of urinary tract Cattle, pigs, rabbits, Enrofloxacin Annex I bovine, porcine, poultry, rabbits infections and septicaemia chicken, turkey Danofloxacin Annex III porcine Broad spectrum penicillins: Amoxicillin Annex I all food producing species 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 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 Diazepam Anxiety related behavioural Cattle, sheep, goats, pigs, No alternatives problems and animal horses, poultry, donkey aggressiveness. Treatment of (Alternatives with other mode of convulsions in hypoxic action, e.g. , but no MRL) neonatal animals Fluanisone + Neuroleptanalgesia Rabbits Only used for pets and laboratory animals, i.e. not relevant for food producing animals

3 Species, indicated by Member States 4 CVMP recommendations not yet published in the OJ are written in italics 14 October 1999 14/16 ãEMEA 1999 Substances Indication Species3 Examples for alternatives MRL Status for these alternatives4 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. 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 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 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 Etorphine Neuroleptanalgesia Cattle No alternatives 14 October 1999 15/16 ãEMEA 1999 Substances Indication Species3 Examples for alternatives MRL Status for these alternatives4 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

14 October 1999 16/16 ãEMEA 1999

Top View