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
Date: 2025-05-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, drugs classification, equidae, marketing standard, veterinary inspection, veterinary medicinal product, veterinary medicine




L_202500901EN.000101.fmx.xml












Official Journal of the European Union


EN
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)