Commission Implementing Regulation (EU) 2025/901 of 19 May 2025 establishing a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months and repealing Regulation (EC) No 1950/2006

ANNEXGroups of substances
ANNEX
Groups of substances
I.    Anaesthetics
Active substance  ( 1 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Oxybuprocaine a
Local topical anaesthesia for use in eyes
None identified
Wide clinical experience
Prilocaine b
Local topical anaesthesia prior to intravenous injection or catheterisation
Lidocaine
In specific preparations (eutectic mixture of local anaesthetics), for topical application to skin; can be used to facilitate intravenous injection or catheterisation
II.    Analgesics
Active substance  ( 2 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Bromfenac b
Treatment of uveitis and ocular inflammation
Systemic nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. flunixin); topical (ocular) ketorolac
Topical NSAIDs may result in less patient discomfort, reduced postoperative inflammation, prevention of miosis, and improvements in visual acuity in the early postoperative period
Fentanyl b
Multimodal approach for moderate to severe acute painful conditions
Butorphanol, morphine
Produces better analgesia than certain other opioids and can be used for very painful conditions; recognized value for use in multi-modal approaches
Ketorolac b
Treatment of eye pain and inflammation
Systemic NSAID therapy (e.g. flunixin)
Formulated for local application
Methocarbamol b
As part of treatment protocols in severe painful muscle spasms or severe muscle inflammation conditions
Systemic NSAIDs (e.g. flunixin)
Potent skeletal muscle relaxation; specific action on the internuncial neurons of the spinal cord to reduce acute skeletal muscle spasms without a concomitant alteration in muscle tone
Morphine b
Analgesia
Butorphanol, fentanyl
More potent than other analgesics
Triamcinolone acetonide b
Treatment of joint inflammation
Methylprednisolone
Less harmful effects on cartilage metabolism
III.    Antimicrobials
Active substance  ( 3 )
Indications
Identification of alternatives
Explanation of use / specific advantages
I.
Antibiotics
Amikacin b
Treatment of septicemia in horses and foals
Gentamicin, ceftiofur
Better safety profile in the target animal
Azithromycin b
Treatment of Rhodococcus equi infections susceptible to azithromycin
Clarithromycin, erythromycin, gamithromycin, tulathromycin, doxycycline
Added clinical benefit in cases of Rhodococcus equi infections in foals that can be resolved as monotherapy or in combination with doxycycline
Clarithromycin b
Treatment of Rhodococcus equi infections susceptible to clarithromycin
Azithromycin, erythromycin, gamithromycin, tulathromycin, doxycycline
More active against Rhodococcus equi in vitro than erythromycin or azithromycin; achieves greater concentrations in pulmonary epithelial lining fluid and alveolar macrophages than either erythromycin or azithromycin, though the half-life is shorter
Fusidic acid b
Topical treatment of eye infections caused by gram-positive bacteria susceptible to fusidic acid
Ofloxacin, moxifloxacin
Broad spectrum for treatment of gram-positive infections; primary choice in superficial, uncomplicated corneal ulcers and acute conjunctivitis in horses
Moxifloxacin b
Topical treatment of external eye infections caused by gram-positive cocci, gram-negative, atypical and anaerobic bacteria, such as Pseudomonas aeruginosa, susceptible to moxifloxacin
Ofloxacin
Advantageous pharmacokinetic profile; spectrum of activity includes gram-positive cocci and anaerobic bacteria that may be resistant to other quinolones
Ofloxacin b
Treatment of external eye infections caused by gram-positive and gram-negative micro-organisms susceptible to ofloxacin
Moxifloxacin
Clinical experience; penetrates the entire cornea up to the anterior chamber of the eye
Polymyxin B b
Treatment of bacterial keratitis, topical use
Ofloxacin, moxifloxacin
Effective alternative to systemic treatments; different mechanism of action to other topical alternatives
II.
Antifungals
Amphotericin B a
Treatment of fungal pneumonia, systemic use
None identified
Treatment of choice
Miconazole b
Treatment of fungal infection of the eye
Natamycin, nystatin, voriconazole
Broad spectrum of activity; less irritant compared to other topical antifungals
Nystatin b
Treatment of fungal and yeast infections of the eye and genital tract
Miconazole
Treatment of choice for yeast infections
Voriconazole b
Treatment of fungal keratitis, topical use
Miconazole
Broad spectrum of activity
III.
Antivirals
Aciclovir b
Treatment of cases of equine herpes virus infection associated with complications, topical use only
Ganciclovir
Treatment of choice for ocular ulcers when the implication of a viral pathogen is suspected
Ganciclovir b
Treatment of cases of equine herpes virus infection associated with complications, topical use
Aciclovir, valaciclovir
Wealth of evidence for the treatment of different virus-types causing herpetic infections
Valaciclovir b
Treatment of cases of equine herpes virus infections, oral use
Aciclovir
Better pharmacokinetic profile and a different route of administration
IV.    Substances for respiratory disorders
Active substance  ( 4 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Ambroxol b
Stimulation of surfactant in premature foals
Steroids, bromhexine, dembrexine, surfactant transfer from healthy donor
Preferred clinical choice for premature foals
Fluticasone b
Control of allergic pulmonary disease including mild to moderate cases of equine asthma and subtypes via inhalation
Beclomethasone
Inhalation leads to less adreno-cortical suppression, quicker rebound after therapy ends and fewer systemic side effects than systemic corticosteroid therapy because of its limited systemic absorption; especially indicated for control of mild-moderate and refractory severe asthma as well as long-term maintenance therapy
Ipratropium bromide b
As a bronchodilator in horses with mild-moderate asthma
Clenbuterol
Anticholinergic action, as an alternative to beta-agonists
Oxymetazoline b
Treatment of nasal oedema
Phenylephrine
Alpha-adrenoceptor agonist with strong vasoconstrictive properties and longer acting effect
Phenylephrine b
Treatment of nasal oedema
Oxymetazoline
Reduces the need for insertion of nasal tubes during recovery
V.    Substances for cardiology
Active substance  ( 5 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Amiodarone b
Systemic and oral treatment of atrial fibrillation, supraventricular and ventricular tachycardias
Quinidine sulphate/gluconate, sotalol, verapamil
Different mode of action: class III anti-dysrhythmic
Propafenone b
Treatment of ventricular tachycardia and ventricular tachyarrhythmia
Quinidine sulphate/gluconate
Different mode of action: sodium channel antagonist that decreases heart excitability
Quinapril a
Treatment of heart failure; cardiovascular protection in horses with atrial fibrillation (AF) or mitral regurgitation (MR)
None identified
Different mode of action: angiotensin-converting-enzyme (ACE) inhibitor
Quinidine sulphate/gluconate b
Treatment of cardiac arrhythmias
Amiodarone, sotalol, verapamil
Treatment of choice for atrial fibrillation
Sotalol b
Long-term treatment of cardiac arrhythmias
Amiodarone, quinidine sulphate/gluconate
More suitable in horses requiring long-term anti-arrhythmic therapy; less adverse events than amiodarone
Verapamil b
Treatment of supraventricular arrhythmias
Amiodarone, quinidine sulphate/gluconate, sotalol
Different mode of action: calcium channel blocker
VI.    Substances for diagnostic procedures
Active substance  ( 6 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Barium sulfate a
Enhanced gastrointestinal tract visualization during radiographic examinations
None identified
No satisfactory alternative treatment for enhanced gastrointestinal tract visualisation during radiographic examinations
Fluorescein b
Diagnosing corneal keratitis or ulceration, topical use
Rose bengal
Diagnostic tool of choice when a viral culture is needed afterwards
Iohexol a
Contrast agent for lower urinary tract radiography, arthrography, myelography, sino- or fistulography and dacryocystography
None identified
Non-ionic, water-soluble contrast agent
Phenylephrine a
Diagnosing grass sickness
None identified
Ancillary diagnostic approach to equine grass sickness polyneuropathy
Rose bengal b
Diagnosing corneal keratitis or ulceration, topical use
Fluorescein
Diagnostic tool of choice for diagnosing eye keratitis/ulcers
Thyrotropin releasing hormone a
Diagnosing pituitary pars intermedia dysfunction
None identified
No satisfactory alternatives for diagnosing pituitary pars intermedia dysfunction
VII.    Substances for gastrointestinal disorders
Active substance  ( 7 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Metoclopramide b
Treatment of post-operative ileus
Intravenous fluid substitution, painkillers (e.g. flunixin), lidocaine
Prokinetic drug
Misoprostol b
Treatment of gastric glandular disease and colitis
Omeprazole, sucralfate
Superior to omeprazole for the treatment of equine gastric glandular disease
Phenylephrine a
Treatment of nephrosplenic entrapment
None identified
Clinical value in the resolution of nephrosplenic entrapment; causes a dose-dependent splenic contraction
Ranitidine b
Treatment of gastric ulcers in critically ill neonates, intravenous use
Omeprazole
The intravenous route of administration brings added clinical benefit over other oral antiulcer medications
Sucralfate b
Treatment and prevention of gastric ulcers in horses
Omeprazole
Different mode of action than omeprazole (mucosal adherent), which provides physical lesion stabilisation
VIII.    Substances for metabolic disorders
Active substance  ( 8 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Insulin b
As an aid in the treatment of hyperlipidaemia unresponsive to glucose therapy or severe hyperlipidaemia, used in combination with glucose and other therapies
Diagnosing metabolic disorders (e.g. insulin resistance associated with equine metabolic syndrome or pituitary pars intermedia dysfunction)
Low-molecular weight heparin can be used for cases of hyperlipidaemia
Insulin is the preferred clinical choice
IX.    Substances for musculoskeletal disorders
Active substance  ( 9 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Atracurium b
Inducing muscle paralysis under general anaesthesia
Cisatracurium, guaifenesin
Brings added clinical benefit in horses under general anaesthesia in cases where increased muscle relaxation is necessary such as ophthalmic surgeries, certain orthopaedic repairs and when deep access to the abdominal cavity is needed.
Cisatracurium b
Inducing muscle paralysis under general anaesthesia
Atracurium, guaifenesin
Brings added clinical benefit in horses under general anaesthesia in cases where increased muscle relaxation is necessary such as ophthalmic surgeries, certain orthopaedic repairs and when deep access to the abdominal cavity is needed.
Dantrolene sodium b
Prevention of rhabdomyolysis
Prevention of malignant hyperthermia during anaesthesia
NSAIDs, intravenous fluids, vitamin E/selenium
Efficacious as preventative, inhibiting the release of calcium from the sarcoplasmic reticulum and thus causing dissociation of excitation-contraction coupling
Edrophonium a
Reversing the effects of atracurium muscle paralysis
None identified
Cholinesterase inhibitor, essential for reversal of neuromuscular blockade; least side effects of the cholinesterase inhibitors in horses
Guaifenesin b
Induction and maintenance of general anaesthesia in field conditions
Atracurium, cisatracurium
Particularly indicated in field (non-hospital) conditions where anaesthesia may be necessary; the reduced cardiopulmonary depressive effects facilitate safe anaesthesia without advanced monitoring equipment or mechanical ventilation
X.    Substances for nervous system disorders
Active substance  ( 10 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Diazepam a
Short-term anti-convulsant for treatment of seizures
None identified
Second-generation antiseizure
XI.    Substances for ophthalmology
Active substance  ( 11 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Acetazolamide b
Treatment of glaucoma, oral use
Phenylephrine
Its mechanism of action as carbonic anhydrase inhibitor
Cyclopentolate b
Mydriatic agent
Atropine, phenylephrine
Induces significant mydriasis without affecting tear production, intraocular pressure, digestive function (i.e. gut motility and faeces production), or heart rate
Cyclosporine A b
Treatment of autoimmune diseases of the eye
Topical steroids
Immunosuppressive effect by inhibiting T-lymphocyte proliferation and reducing cytokine gene expression
Phenylephrine b
Treatment of glaucoma and epiphora
Atropine and tropicamide
It does not (or only slightly) increase intraocular pressure
Synephrine b
Treatment of the mucous membranes of the eye as a decongestant
Phenylephrine, tetryzoline
Fast local effect; enhances penetration of local therapy, providing synergistic effects with e.g. local antimicrobial therapy
Tetryzoline b
Treatment of the mucous membranes of the eye as a decongestant
Phenylephrine, synephrine
Fast local effect
Timolol maleate b
Treatment of glaucoma, topical use
Acetazolamide
Its specific mode of action as a non-selective beta-adrenergic receptor blocking agent, provides for an important therapeutic choice in the treatment of glaucoma
Triamcinolone acetonide b
Treatment of recurrent uveitis in cases that are refractory to other treatments
Atropine, tropicamide
Effective, low-morbidity treatment in cases that are refractory to other treatments
Tropicamide b
Treatment of recurrent uveitis
Atropine, cyclopentolate, triamcinolone acetonide
Rapid onset of action
XII.    Substances for sedation and premedication (and antagonism)
Active substance  ( 12 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Acepromazine b
For a multimodal approach for tranquilisation and premedication in combination with other sedatives
Detomidine, romifidine, xylazine, diazepam
The mode of action of acepromazine and its unique quality of sedation cannot be produced by alpha-2 agonist sedatives or benzodiazepines
Atipamezole a
Reversing the effects of alpha-2 agonists
None identified
Reverses sedative and analgesic effects and adverse cardiovascular reactions
Dexmedetomidine b
Sedation or general anaesthesia as part of partial or total intravenous anaesthesia protocols
Detomidine, romifidine, xylazine, diazepam
The most selective alpha-2 agonist; short half-life and rapid redistribution, which particularly favour its use as a continuous-rate infusion
Diazepam b
Premedication and induction of anaesthesia, mild tranquilisation with minimal cardiovascular and respiratory side effects
Acepromazine, detomidine, romifidine, xylazine
The mode of action (at gamma-aminobutyric acid (GABA) receptor) provides unique tranquilisation without cardiorespiratory depression that cannot be produced by alpha-2 agonist sedatives (detomidine, romifidine and xylazine) or acepromazine
Flumazenil a
Intravenous reversal agent for benzodiazepine effect during recovery from Total Intravenous Anaesthesia (TIVA) techniques
None identified
Antagonist that competitively inhibits the benzodiazepine binding site at the GABA receptor
Naloxone a
Reversal of opioid effects during emergencies
None identified
No alternatives available
Propofol b
Induction of anaesthesia in foals via intravenous administration
Isoflurane
Improvement in cardiovascular stability and quality of recovery over inhalation anaesthesia in foals
XIII.    Substances for systemic disorders
Active substance  ( 13 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Allopurinol b
Neonatal ischaemia reperfusion injury
Vitamin E
Different mode of action in inhibiting the formation of reactive oxygen species (ROS) than vitamin E
Dalteparin b
Anticoagulant
Heparin
Reduction in molecular size is associated with a loss of thrombin inhibitory activity, but conversely an increase in factor Xa (FXa) inhibition compared to unfractionated heparin
Dobutamine b
Management of hypotension under general anaesthesia
Ephedrine
First-line medication for the treatment of hypotension in adult equines under general anaesthesia
Dopamine a
As part of a treatment protocol for acute kidney injury /renal failure only
None identified
Low doses have been shown to cause renal vasodilation, increased renal blood flow, and increased urine production without systemic cardiovascular effects in conscious healthy horses
Ephedrine b
Treatment of hypotension under general anaesthesia
Dobutamine
Used to treat hypotension in adult equines under general anaesthesia where dobutamine is ineffective. Different mode of action to dobutamine with a more direct effect on cardiac contractility
Gelatinpolysuccinate b
Addressing long-term hypovolaemia resulting from conditions like e.g. low albumin
Crystalloids
Colloids are larger molecules compared to crystalloids, thus stay longer in the intravascular space, which is an advantage for correcting hypovolemia from e.g. hypoalbuminemia
Glycopyrrolate b
Treatment and prevention of bradycardia
Atropine
Minimal central effect; suitable in conscious horses, before and after anaesthesia
Noradrenaline/
norepinephrine b
Treatment of early septic shock
Supporting cardiovascular function in critically ill foals
Dobutamine, dopamine
In compromised (sick) foals it is generally the only catecholamine effective in treatment of hypotension
Vasopressin b
Treatment of circulatory collapse in foals and adult horses
Epinephrine, dopamine, dobutamine
Alternative in cases where standard catecholamine therapies like dopamine, dobutamine, epinephrine are ineffective or require potentiation to restore vascular tone in refractory vasodilatory shock states
XIV.    Substances for tumours
Active substance  ( 14 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Imiquimod a
Treatment of sarcoids
None identified
Current research suggests that equine sarcoids likely result from a complex interaction including host immune system dysfunction
XV.    Miscellaneous
Active substance  ( 15 )
Indications
Identification of alternatives
Explanation of use / specific advantages
Cetirizine b
Treatment of conditions where an antihistamine is deemed necessary
Chlorphenamine
Second-generation histamine-1 (H1) receptor inverse agonists are alternatives with fewer central nervous system (CNS) (sedative) side effects
Domperidone b
Treatment of agalactia/dysgalactia in mares
Sulpiride
Its ability to stimulate prolactin secretion in situations of dopaminergic inhibition
Sulpiride b
Treatment of agalactia/dysgalactia in mares
Domperidone
Its ability to stimulate prolactin secretion in situations of dopaminergic inhibition
( 1 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 2 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 3 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 4 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 5 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 6 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 7 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 8 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 9 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 10 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 11 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 12 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 13 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 14 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
( 15 )   Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.
Schedules & Appendices

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