32025R0901

EUR-Lex

Access to European Union law

This document is an excerpt from the EUR-Lex website

EUROPA
EUR-Lex home
Implementing regulation - EU - 2025/901 - EN - EUR-Lex

Help

Search tips

Need more search options? Use the Advanced search

Document 32025R0901

Help

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

C/2025/3016

OJ L, 2025/901, 20.5.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/901/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

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

HTML

PDF - authentic OJ

e-signature

How to verify the authenticity of the Official Journal

Official Journal
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.

(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,

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

(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).

(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).

ANNEX

Groups of substances

I. Anaesthetics

Active substance (1)	Indications	Identification of alternatives	Explanation of use / specific advantages
Oxybuprocainea	Local topical anaesthesia for use in eyes	None identified	Wide clinical experience
Prilocaineb	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
Bromfenacb	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
Fentanylb	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
Ketorolacb	Treatment of eye pain and inflammation	Systemic NSAID therapy (e.g. flunixin)	Formulated for local application
Methocarbamolb	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
Morphineb	Analgesia	Butorphanol, fentanyl	More potent than other analgesics
Triamcinolone acetonideb	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

Amikacinb

Treatment of septicemia in horses and foals

Gentamicin, ceftiofur

Better safety profile in the target animal

Azithromycinb

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

Clarithromycinb

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 acidb

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

Moxifloxacinb

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

Ofloxacinb

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 Bb

Treatment of bacterial keratitis, topical use

Ofloxacin, moxifloxacin

Effective alternative to systemic treatments; different mechanism of action to other topical alternatives

II.	Antifungals

Amphotericin Ba

Treatment of fungal pneumonia, systemic use

None identified

Treatment of choice

Miconazoleb

Treatment of fungal infection of the eye

Natamycin, nystatin, voriconazole

Broad spectrum of activity; less irritant compared to other topical antifungals

Nystatinb

Treatment of fungal and yeast infections of the eye and genital tract

Miconazole

Treatment of choice for yeast infections

Voriconazoleb

Treatment of fungal keratitis, topical use

Miconazole

Broad spectrum of activity

III.	Antivirals

Aciclovirb

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

Ganciclovirb

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

Valaciclovirb

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
Ambroxolb	Stimulation of surfactant in premature foals	Steroids, bromhexine, dembrexine, surfactant transfer from healthy donor	Preferred clinical choice for premature foals
Fluticasoneb	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 bromideb	As a bronchodilator in horses with mild-moderate asthma	Clenbuterol	Anticholinergic action, as an alternative to beta-agonists
Oxymetazolineb	Treatment of nasal oedema	Phenylephrine	Alpha-adrenoceptor agonist with strong vasoconstrictive properties and longer acting effect
Phenylephrineb	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
Amiodaroneb	Systemic and oral treatment of atrial fibrillation, supraventricular and ventricular tachycardias	Quinidine sulphate/gluconate, sotalol, verapamil	Different mode of action: class III anti-dysrhythmic
Propafenoneb	Treatment of ventricular tachycardia and ventricular tachyarrhythmia	Quinidine sulphate/gluconate	Different mode of action: sodium channel antagonist that decreases heart excitability
Quinaprila	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/gluconateb	Treatment of cardiac arrhythmias	Amiodarone, sotalol, verapamil	Treatment of choice for atrial fibrillation
Sotalolb	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
Verapamilb	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 sulfatea	Enhanced gastrointestinal tract visualization during radiographic examinations	None identified	No satisfactory alternative treatment for enhanced gastrointestinal tract visualisation during radiographic examinations
Fluoresceinb	Diagnosing corneal keratitis or ulceration, topical use	Rose bengal	Diagnostic tool of choice when a viral culture is needed afterwards
Iohexola	Contrast agent for lower urinary tract radiography, arthrography, myelography, sino- or fistulography and dacryocystography	None identified	Non-ionic, water-soluble contrast agent
Phenylephrinea	Diagnosing grass sickness	None identified	Ancillary diagnostic approach to equine grass sickness polyneuropathy
Rose bengalb	Diagnosing corneal keratitis or ulceration, topical use	Fluorescein	Diagnostic tool of choice for diagnosing eye keratitis/ulcers
Thyrotropin releasing hormonea	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
Metoclopramideb	Treatment of post-operative ileus	Intravenous fluid substitution, painkillers (e.g. flunixin), lidocaine	Prokinetic drug
Misoprostolb	Treatment of gastric glandular disease and colitis	Omeprazole, sucralfate	Superior to omeprazole for the treatment of equine gastric glandular disease
Phenylephrinea	Treatment of nephrosplenic entrapment	None identified	Clinical value in the resolution of nephrosplenic entrapment; causes a dose-dependent splenic contraction
Ranitidineb	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
Sucralfateb	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

Insulinb

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
Atracuriumb	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.
Cisatracuriumb	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 sodiumb	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
Edrophoniuma	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
Guaifenesinb	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
Diazepama	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
Acetazolamideb	Treatment of glaucoma, oral use	Phenylephrine	Its mechanism of action as carbonic 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 autoimmune diseases of the eye	Topical steroids	Immunosuppressive effect by inhibiting T-lymphocyte proliferation and reducing cytokine gene expression
Phenylephrineb	Treatment of glaucoma and epiphora	Atropine and tropicamide	It does not (or only slightly) increase intraocular pressure
Synephrineb	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
Tetryzolineb	Treatment of the mucous membranes of the eye as a decongestant	Phenylephrine, synephrine	Fast local effect
Timolol maleateb	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 acetonideb	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
Tropicamideb	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
Acepromazineb	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
Atipamezolea	Reversing the effects of alpha-2 agonists	None identified	Reverses sedative and analgesic effects and adverse cardiovascular reactions
Dexmedetomidineb	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
Diazepamb	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
Flumazenila	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
Naloxonea	Reversal of opioid effects during emergencies	None identified	No alternatives available
Propofolb	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
Allopurinolb	Neonatal ischaemia reperfusion injury	Vitamin E	Different mode of action in 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 hypotension under general anaesthesia	Ephedrine	First-line medication for the treatment of hypotension in adult equines under general anaesthesia
Dopaminea	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
Ephedrineb	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
Gelatinpolysuccinateb	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
Glycopyrrolateb	Treatment and prevention of bradycardia	Atropine	Minimal central effect; suitable in conscious horses, before and after anaesthesia
Noradrenaline/ norepinephrineb	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
Vasopressinb	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
Imiquimoda	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
Cetirizineb	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
Domperidoneb	Treatment of agalactia/dysgalactia in mares	Sulpiride	Its ability to stimulate prolactin secretion in situations of dopaminergic inhibition
Sulpirideb	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.

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

ISSN 1977-0677 (electronic edition)

Top

Choose the experimental features you want to try