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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2008-000228-13
    Sponsor's Protocol Code Number:EFC10572
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2008-000228-13
    A.3Full title of the trial
    Estudio multinacional, multicéntrico, aleatorizado y doble ciego para comparar la eficacia y seguridad de AVE5026 con enoxaparina para la prevención primaria de tromboembolismo venoso (TVE) en pacientes médicos agudos con movilidad restringida.

    A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients with Restricted Mobility
    A.4.1Sponsor's protocol code numberEFC10572
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAVE5026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAVE5026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEnoxaparina
    D.3.2Product code XRP4563
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparina
    D.3.9.2Current sponsor codeXRP4563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEnoxaparina
    D.3.2Product code XRP4563
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparina
    D.3.9.2Current sponsor codeXRP4563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Los pacientes que participarán en este ensayo son pacientes médicos agudos con movilidad restringida.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia de inyecciones subcutáneas (s.c.) una vez al día (1 vez/día) de 20 mg de AVE5026 (10 mg en pacientes con insuficiencia renal grave [IRG]) con inyecciones s.c. 1 vez/día de 40 mg de enoxaparina (20 mg en pacientes con IRG) administradas durante 10-14 días para la prevención primaria de episodios de tromboembolismo venoso (TEV) en pacientes hospitalizados por enfermedad aguda no quirúrgica.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad de AVE5026 en pacientes hospitalizados por enfermedad aguda no quirúrgica y documentar las exposiciones de AVE5026 en esta población.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Condición médica aguda no quirúrgica que requiere reposo en cama durante al menos 3
    2.Edad≥40 años
    3.Hospitalización debida a al menos una de las siguientes patologías:
    -Insuficiencia cardiaca congestiva (clase III/IV de la NYHA)
    -Insuficiencia respiratoria aguda (que no requiera ventilación mecánica)
    -Infección aguda (sin choque séptico)*
    -Trastorno reumático agudo*
    -Episodio activo de enfermedad intestinal inflamatoria*
    *Los pacientes con estas patologías deben presentar al menos un factor de riesgo adicional de TEV
    4.Firma del consentimiento informado por escrito
    E.4Principal exclusion criteria
    Criterios de exclusión relacionados con la metodología del estudio:
    1.Cirugía previa con anestesia general en los 30 días anteriores la inclusión.
    2.Cirugía mayor programada durante el periodo del tratamiento en investigación.
    3.Tratamiento con otros antitrombóticos en las 2 semanas anteriores a la aleatorización o programado en el transcurso del estudio, como:
    -anticoagulantes parenterales (HNF, HBPM [p. ej., enoxaparina, dalteparina, nadroparina], fondaparinux, bivalirudina, hirudina)
    Nota: puede incluirse a un paciente si se ha iniciado la tromboprofilaxis con una dosis única de HNF o HBPM administrada como mínimo 12 horas antes de la aleatorización.
    -anticoagulantes orales (antagonistas de la vitamina K)
    -antagonistas de GPIIb/IIIa: abciximab, eptifibatida, tirofibán
    -Trombolíticos.
    Nota: está permitido el tratamiento crónico con antiagregantes plaquetarios como ácido acetilsalicílico a dosis bajas (hasta 325 mg/día), clopidogrel o ticlopidina en pacientes con enfermedades coronarias.
    4.Pacientes que requieren un anticoagulante curativo o un tratamiento trombolítico
    5.Ictus agudo.
    6.Pacientes que sea improbable que cumplan el protocolo, es decir, actitud poco cooperativa, incapacidad para dar el consentimiento informado, regresar para las visitas de seguimiento, incapacidad para recibir la inyección diaria (por un profesional sanitario) después del alta hospitalaria e improbabilidad de finalizar el estudio.
    7.Tratamiento con un fármaco en investigación o un producto sanitario en investigación en los últimos 30 días o 5 vidas medias (si procede) antes de la aleatorización.
    8. Exposición previa a AVE5026 (p. ej., participación en un ensayo clínico previo con AVE5026).
    9.Supervivencia previsible < 6 meses
    Nota:no puede admitirse a un paciente en el estudio más de una vez (es decir, más de una asignación aleatoria).

    Criterios de exclusión relacionados con la enoxaparina:
    10.Hemorragia mayor activa
    11.Trombocitopenia asociada a una prueba in vitro positiva de anticuerpos antiplaquetarios en presencia de enoxaparina sódica
    12.Hipersensibilidad conocida a la enoxaparina sódica (p. ej., prurito, urticaria, reacciones anafilactoides).
    13.Hipersensibilidad conocida a la heparina o a productos porcinos
    14.Enfermedades con un mayor riesgo de hemorragias, como endocarditis bacteriana, trastornos hemorrágicos congénitos o adquiridos, enfermedades gastrointestinales ulcerosas y angiodisplásicas activas, ictus hemorrágico o poco después de cirugía cerebral, vertebral u oftalmológica.

    Criterios de exclusión relacionados con AVE5026
    15.Insuficiencia renal terminal (aclaramiento de creatinina estimado < 10 ml/min o pacientes en diálisis.
    16.Mujeres embarazadas o en período de lactancia
    17.Mujeres en edad fértil no protegidas con un método anticonceptivo muy eficaz según la definición de anticoncepción establecida en el Formulario de consentimiento informado durante el periodo del estudio, o que no desean o no son aptas para que se les realice una prueba de embarazo.
    Nota: el estado del embarazo se examinará con una prueba del embarazo en suero u orina antes de la exposición al producto en investigación
    E.5 End points
    E.5.1Primary end point(s)
    EL criterio principal de valoración de la eficacia es una combinación de los siguientes acontecimientos registrados hasta el día 15 o hasta el día de la ecografía por compresión (CUS) preceptiva (Día 10-15), lo que suceda primero, y confirmados por un Comité de adjudicación en condiciones de enmascaramiento:
    •TVP proximal asintomática detectada por CUS.
    •TVP confirmada o embolia pulmonar (EP) no mortal en caso de síntomas anteriores a la fecha de la CUS preceptiva.
    •Muertes relacionadas con TEV (EP fatal o muertes por causa desconocida).
    Debe realizarse una CUS preceptiva antes de un día natural después de la última dosis. Los resultados de la CUS preceptiva serán adjudicados por un Comité de adjudicación de CUS central en condiciones de enmascaramiento y sólo se tendrán en cuenta los resultados de la adjudicación

    Otros criterios:
    • Cada uno de los componentes del criterio principal de valoración de la eficacia hasta el día 15 o hasta el día de la CUS preceptiva (lo que suceda primero).
    •Inicio del tratamiento curativo por el investigador tras la evaluación local de TEV

    Los parámetros de seguridad incluyen hemorragia mayor, hemorragia no mayor clínicamente relevante (adjudicada por un Comité de adjudicación en condiciones de enmascaramiento), necesidad de transfusiones, hemoglobina, recuento de plaquetas, datos clínicos hepáticos y renales, AA(G) y mortalidad total (clasificada como muerte relacionada con TEV, hemorragia mortal u otras por un Comité de adjudicación en condiciones de enmascaramiento) hasta 3 días naturales después de la última inyección del PI y hasta el día 42.
    Farmacocinética:
    Se recogerán 4 muestras de sangre por paciente, de todos los pacientes de los centros selecionados para documentar la exposición al AVE5026 de estos pacientes.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA246
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months33
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6756
    F.4.2.2In the whole clinical trial 12300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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