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(had to be withdrawn later, as no product containing the substance has ever been licensed for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

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EMEA 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.

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 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 Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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
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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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
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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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 Amitraz 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

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
Dichlorvos Treatment of helmin- Pigs, horses Withdrawn Diazinon Annex I bovine, ovine, caprine, porcine
thoses and control of Phoxim Annex III porcine
internal and external Ivermectin 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)
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
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 Cyfluthrin 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
Cypermethrin Annex III bovine, ovine, caprine, chicken,
salmonidae
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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
Metrifonate 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
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
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
Diphenhydramine 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

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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 bromide Annex II all food producing species
hydrochloride pigs
Chloral hydrate General anaesthesia Cattle, pigs, Withdrawn Ketamine in combination with Annex II all food producing mammalian
horses species
Xylazine hydrochloride Annex II bovine, equidae
Chloroform General anaesthesia No Annex IV Not of importance
information
Isoflurane 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. barbiturates, but no MRL)
in hypoxic neonatal donkey
animals
Narcobarbital General anaesthesia Pigs Withdrawn No alternatives

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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)
Testosterone 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 Tolfenamic acid Annex I bovine, porcine

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
Meclofenamic acid 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
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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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 alcohol 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

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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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
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 Substances Indication Species 1 MRL Status Examples for alternatives MRL Status for these alternatives 2
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

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