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

Official Journal EN of the European Union L series 2025/901 20.5.2025 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 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC(1), and in particular Article 115(5) thereof,

Whereas:

(1) Regulation (EU) 2019/6 lays down rules for use of veterinary medicinal products, including the requirement to use them in accordance with the terms of their marketing authorisations. Where there is no veterinary medicinal product authorised or available in a Member State for food-producing animals of the equine species or for an indication, veterinarians may, in particular to avoid causing unacceptable suffering and under their direct responsibility, use medicinal products outside the terms of their marketing authorisations, in accordance with the rules laid down in Articles 113 and 115 of that Regulation.

(2) In order to increase the availability of medicinal products to food-producing animals of the equine species while ensuring a high level of consumer protection, and by way of derogation from Article 113(1) and (4) of Regulation

(EU) 2019/6, Article 115(5) of Regulation (EU) 2019/6 provides for the establishment, by means of implementing acts, of 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.

(3) Commission Regulation (EC) No 1950/2006(2), as amended by Regulation (EU) No 122/2013(3), had established a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit.

(4) The Annex to Regulation (EC) No 1950/2006 was last updated in 2013 by means of Regulation (EU) No 122/2013.

Therefore, the experience gained from using the substances listed in that Annex should serve as basis for establishing the list referred to in Article 115(5) of Regulation (EU) 2019/6, including the need to update the information on use of those substances, their advantages and alternatives. Furthermore, the need to add other substances as a result of newly available evidence should also be considered.

(5) To ensure a high level of consumer protection, substances should only be included in the list set out in this Regulation where they do not pose an unacceptable risk to consumers when used in food-producing animals of the equine species and a six-month withdrawal period is respected.

(1) OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj.

(2) Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit (OJ L 367, 22.12.2006, p. 33, ELI: http://data.

europa.eu/eli/reg/2006/1950/oj).

(3) Commission Regulation (EU) No 122/2013 of 12 February 2013 amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (OJ L 42, 13.2.2013, p. 1, ELI: http://data.europa.eu/eli/ reg/2013/122/oj).

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 1/13EN OJ L, 20.5.2025

(6) A substance only qualifies as an ‘essential substance’ where no satisfactory alternative for the treatment or diagnosis of an indication is available and where the condition would, if untreated, create unnecessary suffering for the animal.

A substance only qualifies as ‘bringing added clinical benefit’ where it provides a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment or diagnosis. This may be the result, inter alia, of different modes of action, different pharmacokinetic or pharmacodynamic profiles, different lengths of treatment or different routes of administration.

(7) At the request of the Commission, the European Medicines Agency (‘the Agency’) carried out a scientific evaluation of the substances listed in the Annex to Regulation (EC) No 1950/2006, as well as of the substances that were identified in a survey among the competent authorities and relevant stakeholders. In its scientific advice(4), the Agency identifies some of those substances as ‘essential’ or as ‘bringing added clinical benefit’ and for which a withdrawal period of six months would not pose an unacceptable risk for consumers.

(8) In line with the Agency’s advice, the substances recommended as essential or as bringing added clinical benefit should be used for the specific diseases or conditions, treatment or diagnostic needs specified in the Annex to this Regulation. In addition, the Agency advised that consideration should also be given to the alternatives listed in that Annex.

(9) The substances listed in Tables 1 or 2 in the Annex to Commission Regulation (EU) No 37/2010(5), or substances prohibited for use in stockfarming by Council Directive 96/22/EC(6), do not qualify as essential or bringing added clinical benefit. Therefore, in the event that substances listed in the Annex to this Regulation are also included in Tables 1 or 2 in the Annex to Regulation (EU) No 37/2010, or their use in food-producing animals of the equine species is prohibited by Union legislation, these substances should no longer be used for the purposes of this Regulation.

(10) The list of substances set out in the Annex to this Regulation should replace the list provided for under Regulation

(EC) No 1950/2006. Regulation (EC) No 1950/2006 should be repealed. In order to allow the competent authorities, veterinarians, and animal keepers concerned to adapt to the changes resulting from the non-inclusion in the Annex to this Regulation of some substances or indications listed in the Annex to Regulation (EC) No 1950/2006, a sufficient transitional period should be allowed.

(11) In order to increase the availability of medicinal products to food-producing animals of the equine species and avoid unacceptable suffering, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation should also apply as from the date of its entry into force.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

(4) Scientific advice under Article 115(5) of Regulation (EU) 2019/6 for the establishment of 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 (EMA/CVMP/159047/2023, 18 July 2024).

(5) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/ 37(1)/oj).

(6) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125,

23.5.1996, p. 3, ELI: http://data.europa.eu/eli/dir/1996/22/oj).

2/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025

HAS ADOPTED THIS REGULATION:

Article 1 Scope The list of substances referred to in Article 115(5) of Regulation (EU) 2019/6 is set out in the Annex to this Regulation.

Article 2 Rules on use of substances listed in the Annex

1. Substances which are essential for the treatment of equine species may be used for the indications specified in the Annex to this Regulation, where no veterinary medicinal product authorised for food-producing animals of the equine species or no medicinal product referred to in Article 113 of Regulation (EU) 2019/6 would yield equally satisfactory results in terms of successfully treating the animal or avoiding unnecessary suffering for the animal.

2. Substances which bring added clinical benefit compared to other treatment options may be used for the indications specified in the Annex to this Regulation and taking into account the alternatives listed in that Annex, where they provide a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment compared to veterinary medicinal products authorised for food-producing animals of the equine species or to medicinal products referred to in Article 113 of Regulation (EU) 2019/6.

3. Where any of the substances listed in the Annex to this Regulation are entered in Tables 1 or 2 of the Annex to Regulation (EU) No 37/2010, or their use in food-producing animals of the equine species is prohibited by Union legislation, such substances shall no longer be used for the purposes of this Regulation.

Article 3 Repeal

1. Regulation (EC) No 1950/2006 is repealed with effect from 21 May 2027.

2. References to the repealed Regulation (EC) No 1950/2006 shall be construed as references to this Regulation.

Article 4 Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 21 May 2025.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 May 2025.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 3/13EN OJ L, 20.5.2025 ANNEX Groups of substances I. Anaesthetics Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Oxybuprocainea Local topical anaesthesia None identified Wide clinical experience for use in eyes Prilocaineb Local topical anaesthesia Lidocaine In specific preparations (eutectic prior to intravenous mixture of local anaesthetics), for injection or topical application to skin; can be catheterisation used to facilitate intravenous injection or catheterisation

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

II. Analgesics Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Bromfenacb Treatment of uveitis and Systemic nonsteroidal Topical NSAIDs may result in less ocular inflammation anti-inflammatory drugs patient discomfort, reduced

(NSAIDs) (e.g. flunixin); postoperative inflammation, topical (ocular) ketorolac prevention of miosis, and improvements in visual acuity in the early postoperative period Fentanylb Multimodal approach Butorphanol, morphine Produces better analgesia than for moderate to severe certain other opioids and can be acute painful conditions used for very painful conditions;

recognized value for use in multi- modal approaches Ketorolacb Treatment of eye pain Systemic NSAID therapy Formulated for local application and inflammation (e.g. flunixin) Methocarbamolb As part of treatment Systemic NSAIDs (e.g. Potent skeletal muscle relaxation;

protocols in severe flunixin) specific action on the internuncial painful muscle spasms neurons of the spinal cord to reduce or severe muscle acute skeletal muscle spasms inflammation without a concomitant alteration in conditions muscle tone Morphineb Analgesia Butorphanol, fentanyl More potent than other analgesics Triamcinolone acetonideb Treatment of joint Methylprednisolone Less harmful effects on cartilage inflammation metabolism

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

4/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025 III. Antimicrobials Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages I. Antibiotics Amikacinb Treatment of septicemia Gentamicin, ceftiofur Better safety profile in the target in horses and foals animal Azithromycinb Treatment of Clarithromycin, Added clinical benefit in cases of Rhodococcus equi erythromycin, Rhodococcus equiinfections in foals infections susceptible to gamithromycin, that can be resolved as monotherapy azithromycin tulathromycin, or in combination with doxycycline doxycycline Clarithromycinb Treatment of Azithromycin, More active against Rhodococcus equi Rhodococcus equi erythromycin, in vitro than erythromycin or infections susceptible to gamithromycin, azithromycin; achieves greater clarithromycin tulathromycin, concentrations in pulmonary doxycycline epithelial lining fluid and alveolar macrophages than either erythromycin or azithromycin, though the half-life is shorter Fusidic acidb Topical treatment of eye Ofloxacin, moxifloxacin Broad spectrum for treatment of infections caused by gram-positive infections; primary gram-positive bacteria choice in superficial, uncomplicated susceptible to fusidic corneal ulcers and acute acid conjunctivitis in horses Moxifloxacinb Topical treatment of Ofloxacin Advantageous pharmacokinetic external eye infections profile; spectrum of activity includes caused by gram-positive gram-positive cocci and anaerobic cocci, gram-negative, bacteria that may be resistant to atypical and anaerobic other quinolones bacteria, such as Pseudomonas aeruginosa, susceptible to moxifloxacin Ofloxacinb Treatment of external Moxifloxacin Clinical experience; penetrates the eye infections caused by entire cornea up to the anterior gram-positive and gram- chamber of the eye negative micro- organisms susceptible to ofloxacin Polymyxin Bb Treatment of bacterial Ofloxacin, moxifloxacin Effective alternative to systemic keratitis, topical use treatments; different mechanism of action to other topical alternatives II. Antifungals Amphotericin Ba Treatment of fungal None identified Treatment of choice pneumonia, systemic use Miconazoleb Treatment of fungal Natamycin, nystatin, Broad spectrum of activity; less infection of the eye voriconazole irritant compared to other topical antifungals

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 5/13EN OJ L, 20.5.2025 Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Nystatinb Treatment of fungal and Miconazole Treatment of choice for yeast yeast infections of the infections eye and genital tract Voriconazoleb Treatment of fungal Miconazole Broad spectrum of activity keratitis, topical use III. Antivirals Aciclovirb Treatment of cases of Ganciclovir Treatment of choice for ocular ulcers equine herpes virus when the implication of a viral infection associated with pathogen is suspected complications, topical use only Ganciclovirb Treatment of cases of Aciclovir, valaciclovir Wealth of evidence for the treatment equine herpes virus of different virus-types causing infection associated with herpetic infections complications, topical use Valaciclovirb Treatment of cases of Aciclovir Better pharmacokinetic profile and a equine herpes virus different route of administration infections, oral use

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

IV. Substances for respiratory disorders Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Ambroxolb Stimulation of surfactant Steroids, bromhexine, Preferred clinical choice for in premature foals dembrexine, surfactant premature foals transfer from healthy donor Fluticasoneb Control of allergic Beclomethasone Inhalation leads to less adreno- pulmonary disease cortical suppression, quicker including mild to rebound after therapy ends and moderate cases of fewer systemic side effects than equine asthma and systemic corticosteroid therapy subtypes via inhalation 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 bromideb As a bronchodilator in Clenbuterol Anticholinergic action, as an horses with mild- alternative to beta-agonists moderate asthma Oxymetazolineb Treatment of nasal Phenylephrine Alpha-adrenoceptor agonist with oedema strong vasoconstrictive properties and longer acting effect Phenylephrineb Treatment of nasal Oxymetazoline Reduces the need for insertion of oedema nasal tubes during recovery

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

6/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025 V. Substances for cardiology Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Amiodaroneb Systemic and oral Quinidine sulphate/ Different mode of action: class III treatment of atrial gluconate, sotalol, anti-dysrhythmic fibrillation, verapamil supraventricular and ventricular tachycardias Propafenoneb Treatment of ventricular Quinidine sulphate/ Different mode of action: sodium tachycardia and gluconate channel antagonist that decreases ventricular heart excitability tachyarrhythmia

Quinaprila Treatment of heart None identified Different mode of action: failure; cardiovascular angiotensin-converting-enzyme protection in horses (ACE) inhibitor with atrial fibrillation

(AF) or mitral regurgitation (MR) Quinidine sulphate/ Treatment of cardiac Amiodarone, sotalol, Treatment of choice for atrial gluconateb arrhythmias verapamil fibrillation Sotalolb Long-term treatment of Amiodarone, quinidine More suitable in horses requiring cardiac arrhythmias sulphate/gluconate long-term anti-arrhythmic therapy;

less adverse events than amiodarone Verapamilb Treatment of Amiodarone, quinidine Different mode of action: calcium supraventricular sulphate/gluconate, channel blocker arrhythmias sotalol

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

VI. Substances for diagnostic procedures Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Barium sulfatea Enhanced None identified No satisfactory alternative treatment gastrointestinal tract for enhanced gastrointestinal tract visualization during visualisation during radiographic radiographic examinations examinations Fluoresceinb Diagnosing corneal Rose bengal Diagnostic tool of choice when a keratitis or ulceration, viral culture is needed afterwards topical use

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 7/13EN OJ L, 20.5.2025 Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Iohexola Contrast agent for lower None identified Non-ionic, water-soluble contrast urinary tract agent radiography, arthrography, myelography, sino- or fistulography and dacryocystography Phenylephrinea Diagnosing grass None identified Ancillary diagnostic approach to sickness equine grass sickness polyneuropathy Rose bengalb Diagnosing corneal Fluorescein Diagnostic tool of choice for keratitis or ulceration, diagnosing eye keratitis/ulcers topical use Thyrotropin releasing Diagnosing pituitary None identified No satisfactory alternatives for hormonea pars intermedia diagnosing pituitary pars intermedia dysfunction dysfunction

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

VII. Substances for gastrointestinal disorders Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Metoclopramideb Treatment of post- Intravenous fluid Prokinetic drug operative ileus substitution, painkillers (e.g. flunixin), lidocaine Misoprostolb Treatment of gastric Omeprazole, sucralfate Superior to omeprazole for the glandular disease and treatment of equine gastric glandular colitis disease Phenylephrinea Treatment of None identified Clinical value in the resolution of nephrosplenic nephrosplenic entrapment; causes a entrapment dose-dependent splenic contraction Ranitidineb Treatment of gastric Omeprazole The intravenous route of ulcers in critically ill administration brings added clinical neonates, intravenous benefit over other oral antiulcer use medications Sucralfateb Treatment and Omeprazole Different mode of action than prevention of gastric omeprazole (mucosal adherent), ulcers in horses which provides physical lesion stabilisation

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

8/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025 VIII. Substances for metabolic disorders Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Insulinb As an aid in the Low-molecular weight Insulin is the preferred clinical choice treatment of heparin can be used for hyperlipidaemia cases 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)

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

IX. Substances for musculoskeletal disorders Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Atracuriumb Inducing muscle Cisatracurium, Brings added clinical benefit in paralysis under general guaifenesin horses under general anaesthesia in anaesthesia cases where increased muscle relaxation is necessary such as ophthalmic surgeries, certain orthopaedic repairs and when deep access to the abdominal cavity is needed.

Cisatracuriumb Inducing muscle Atracurium, guaifenesin Brings added clinical benefit in paralysis under general horses under general anaesthesia in anaesthesia 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 sodiumb Prevention of NSAIDs, intravenous Efficacious as preventative, inhibiting rhabdomyolysis fluids, vitamin E/ the release of calcium from the Prevention of malignant selenium sarcoplasmic reticulum and thus hyperthermia during causing dissociation of excitation- anaesthesia contraction coupling Edrophoniuma Reversing the effects of None identified Cholinesterase inhibitor, essential for atracurium muscle reversal of neuromuscular blockade;

paralysis least side effects of the cholinesterase inhibitors in horses

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 9/13EN OJ L, 20.5.2025 Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Guaifenesinb Induction and Atracurium, Particularly indicated in field (non- maintenance of general cisatracurium hospital) conditions where anaesthesia in field anaesthesia may be necessary; the conditions reduced cardiopulmonary depressive effects facilitate safe anaesthesia without advanced monitoring equipment or mechanical ventilation

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

X. Substances for nervous system disorders Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Diazepama Short-term anti- None identified Second-generation antiseizure convulsant for treatment of seizures

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

XI. Substances for ophthalmology Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Acetazolamideb Treatment of glaucoma, Phenylephrine Its mechanism of action as carbonic oral use anhydrase inhibitor Cyclopentolateb 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 Ab Treatment of Topical steroids Immunosuppressive effect by autoimmune diseases of inhibiting T-lymphocyte the eye proliferation and reducing cytokine gene expression Phenylephrineb Treatment of glaucoma Atropine and It does not (or only slightly) increase and epiphora tropicamide intraocular pressure Synephrineb Treatment of the Phenylephrine, Fast local effect; enhances mucous membranes of tetryzoline penetration of local therapy, the eye as a providing synergistic effects with e.g.

decongestant local antimicrobial therapy Tetryzolineb Treatment of the Phenylephrine, Fast local effect mucous membranes of synephrine the eye as a decongestant 10/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025 Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Timolol maleateb Treatment of glaucoma, Acetazolamide Its specific mode of action as a non- topical use selective beta-adrenergic receptor blocking agent, provides for an important therapeutic choice in the treatment of glaucoma Triamcinolone acetonideb Treatment of recurrent Atropine, tropicamide Effective, low-morbidity treatment in uveitis in cases that are cases that are refractory to other refractory to other treatments treatments Tropicamideb Treatment of recurrent Atropine, Rapid onset of action uveitis cyclopentolate, triamcinolone acetonide

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

XII. Substances for sedation and premedication (and antagonism) Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Acepromazineb For a multimodal Detomidine, romifidine, The mode of action of acepromazine approach for xylazine, diazepam and its unique quality of sedation tranquilisation and cannot be produced by alpha-2 premedication in agonist sedatives or benzodiazepines combination with other sedatives Atipamezolea Reversing the effects of None identified Reverses sedative and analgesic alpha-2 agonists effects and adverse cardiovascular reactions Dexmedetomidineb Sedation or general Detomidine, romifidine, The most selective alpha-2 agonist;

anaesthesia as part of xylazine, diazepam short half-life and rapid partial or total redistribution, which particularly intravenous anaesthesia favour its use as a continuous-rate protocols infusion Diazepamb Premedication and Acepromazine, The mode of action (at gamma- induction of anaesthesia, detomidine, romifidine, aminobutyric acid (GABA) receptor) mild tranquilisation with xylazine provides unique tranquilisation minimal cardiovascular without cardiorespiratory depression and respiratory side that cannot be produced by alpha-2 effects agonist sedatives (detomidine, romifidine and xylazine) or acepromazine Flumazenila Intravenous reversal None identified Antagonist that competitively agent for inhibits the benzodiazepine binding benzodiazepine effect site at the GABA receptor during recovery from Total Intravenous Anaesthesia (TIVA) techniques

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 11/13EN OJ L, 20.5.2025 Active substance(1) Indications Identification of alternatives Explanation of use / specific advantages Naloxonea Reversal of opioid effects None identified No alternatives available during emergencies Propofolb Induction of anaesthesia Isoflurane Improvement in cardiovascular in foals via intravenous stability and quality of recovery over administration inhalation anaesthesia in foals

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

XIII. Substances for systemic disorders Identification of Active substance(1) Indications Explanation of use / specific advantages alternatives Allopurinolb Neonatal ischaemia Vitamin E Different mode of action in reperfusion injury inhibiting the formation of reactive oxygen species (ROS) than vitamin E Dalteparinb 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 Dobutamineb Management of Ephedrine First-line medication for the hypotension under treatment of hypotension in adult general anaesthesia equines under general anaesthesia Dopaminea As part of a treatment None identified Low doses have been shown to protocol for acute cause renal vasodilation, increased kidney injury /renal renal blood flow, and increased failure only urine production without systemic cardiovascular effects in conscious healthy horses Ephedrineb Treatment of Dobutamine Used to treat hypotension in adult hypotension under equines under general anaesthesia general anaesthesia where dobutamine is ineffective.

Different mode of action to dobutamine with a more direct effect on cardiac contractility Gelatinpolysuccinateb Addressing long-term Crystalloids Colloids are larger molecules hypovolaemia resulting compared to crystalloids, thus stay from conditions like longer in the intravascular space, e.g. low albumin which is an advantage for correcting hypovolemia from e.g.

hypoalbuminemia Glycopyrrolateb Treatment and Atropine Minimal central effect; suitable in prevention of conscious horses, before and after bradycardia anaesthesia 12/13 ELI: http://data.europa.eu/eli/reg_impl/2025/901/ojEN OJ L, 20.5.2025 Identification of Active substance(1) Indications Explanation of use / specific advantages alternatives Noradrenaline/ Treatment of early Dobutamine, dopamine In compromised (sick) foals it is norepinephrineb septic shock generally the only catecholamine Supporting effective in treatment of cardiovascular function hypotension in critically ill foals Vasopressinb Treatment of Epinephrine, dopamine, Alternative in cases where standard circulatory collapse in dobutamine catecholamine therapies like foals and adult horses dopamine, dobutamine, epinephrine are ineffective or require potentiation to restore vascular tone in refractory vasodilatory shock states

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

XIV. Substances for tumours Identification of Active substance(1) Indications Explanation of use / specific advantages alternatives Imiquimoda Treatment of sarcoids None identified Current research suggests that equine sarcoids likely result from a complex interaction including host immune system dysfunction

(1) Active substances identified with an ‘a’ are essential substances. Substances identified with a ‘b’ are substances which bring added clinical benefit.

XV. Miscellaneous Identification of Explanation of use / specific Active substance(1) Indications alternatives advantages Cetirizineb Treatment of conditions Chlorphenamine Second-generation histamine-1 where an antihistamine is (H1) receptor inverse agonists are deemed necessary alternatives with fewer central nervous system (CNS) (sedative) side effects Domperidoneb Treatment of agalactia/ Sulpiride Its ability to stimulate prolactin dysgalactia in mares secretion in situations of dopaminergic inhibition Sulpirideb Treatment of agalactia/ Domperidone Its ability to stimulate prolactin dysgalactia in mares 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.

ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj 13/13