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    The EU Clinical Trials Register currently displays   42747   clinical trials with a EudraCT protocol, of which   7039   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-004416-13
    Sponsor's Protocol Code Number:150-CL-040
    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:2009-04-23
    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 number2008-004416-13
    A.3Full title of the trial
    Protocolo del estudio en fase IIb de YM150

    Estudio aleatorizado, doble ciego, con doble simulación y de grupos paralelos para comparar la administración de YM150 dos veces al día y una vez al día con enoxaparina para la prevención de tromboembolismo venoso en pacientes sometidos a artroplastia de cadera programada

    Estudio en fase IIb para evaluar la eficacia y la seguridad de YM150 comparado con enoxaparina en pacientes sometidos a artroplastia de cadera programada


    Protocol for Phase IIb Study of YM150.

    A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery.

    A Phase IIb study to Evaluate the Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects undergoing Elective Hip Replacement Surgery.
    A.3.2Name or abbreviated title of the trial where available
    ONYX-3
    A.4.1Sponsor's protocol code number150-CL-040
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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.3.1Product nameYM150
    D.3.2Product code YM150
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeYM150
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.3.1Product nameYM150
    D.3.2Product code YM150
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeYM150
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.3.1Product nameYM150
    D.3.2Product code YM150
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeYM150
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.2.1.1.1Trade name Lovenox
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis US
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form 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 sódica
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención de tromboembolismo venoso en pacientes sometidos a artroplastia de cadera programada

    Prevention of venous thromboembolism after hip replacement surgery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10043634
    E.1.2Term Thrombosis prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y la seguridad de 15 mg dos veces al día, 30 mg una vez al día, 30 mg dos veces al día y 60 mg una vez al día de YM150 y comparar su eficacia y seguridad con la de enoxaparina, 40 mg una vez al día, en pacientes sometidos a artroplastia programada de cadera.
    E.2.2Secondary objectives of the trial
    ?Identificar la farmacocinética del metabolito activo YM-222714 en pacientes sometidos a artroplastia de cadera programada.
    ?Identificar la relación entre farmacocinética (FC) y parámetros de la coagulación en pacientes sometidos a artroplastia de cadera programada.
    ?Evaluar los efectos de YM150 y enoxaparina en:
    -El estado de salud de los pacientes sometidos a artroplastia de cadera programada,
    -El uso de recursos sanitarios asociado a ambas opciones de tratamiento y
    -La relación coste-efectividad asociada a ambas opciones de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    El paciente es apto para participar en el estudio si cumple todas las condiciones siguientes:
    1.Se ha obtenido el consentimiento informado por escrito [y autorización de la Ley de Responsabilidad y transferibilidad de Seguros de Salud (HIPAA), sólo para los centros de EE.UU.] antes de la selección.
    2.Hombre o mujer ? 18 años de edad.
    3.El paciente tiene programada una artroplastia de cadera.
    E.4Principal exclusion criteria
    El paciente no podrá participar en este estudio si cumpliera alguna de las siguientes condiciones:
    1.Mujer en edad fértil que rechace utilizar un método anticonceptivo médicamente aceptable durante el estudio. (Son métodos anticonceptivos aceptables: anticonceptivos hormonales orales o inyectables, dispositivos intrauterinos, anillos vaginales hormonales, y un diafragma vaginal o un capuchón cervical solamente en combinación con preservativo masculino. Se aconsejará a los varones que usen preservativos además de hacer que su pareja utilice otro método aceptable durante el estudio y en los tres meses siguientes a la última administración).
    2.Mujeres que estén embarazadas o en periodo de lactancia, o cuyo resultado de la prueba de embarazo sea positivo en las 72 horas previas a la aleatorización.
    3.El paciente tiene una hemorragia activa o cualquier afección asociada al aumento de riesgo de hemorragia, incluido un trastorno hemorrágico conocido o trombocitopenia (recuento de plaquetas < 100.000/mm3) en el momento de la selección.
    4.El paciente ha tenido un IM o un ictus en los 3 meses previos a la artroplastia de cadera programada.
    5.El paciente tiene una presión arterial (PA) sistólica persistente de 160 mmHg o mayor, y/o diastólica de 100 mmHg o mayor en la situación basal con o sin tratamiento médico.
    6.El paciente tiene una enfermedad concurrente que, en opinión del investigador, puede interferir con el tratamiento o la evaluación de la seguridad o la finalización del estudio.
    7.El paciente ha sufrido un traumatismo mayor o una cirugía mayor, o una cirugía ocular, de la médula espinal o cerebral en los 3 meses previos a la artroplastia de cadera programada.
    8.El paciente requiere una cirugía mayor programada u otros procedimientos invasivos, en los que sea posible una hemorragia no controlada durante el estudio.
    9.El paciente requiere la administración de medicamentos concomitantes prohibidos (p. ej., anticoagulantes como heparinas, inhibidores de la trombina, cumarinas o ácido acetilsalicílico en dosis >163 mg/día) en cualquier momento durante el periodo que se extiende desde una semana antes del inicio del tratamiento del estudio hasta el final del periodo de tratamiento de 35 días.
    10.El paciente tiene hipersensibilidad o cualquier contraindicación al medio de contraste yodado o a enoxaparina.
    11.El paciente tiene programada la inserción de un catéter permanente intratecal o epidural durante más de 6 horas después del final de la cirugía.
    12.El paciente tiene un aclaramiento de creatinina < 60 ml/min, calculado por la ecuación de Cockcroft-Gault (ver el Anexo 1) en el momento de la selección.
    13.El paciente tiene insuficiencia hepática o presenta valores de AST o ALT > 2 veces el LSN o bilirrubina total > 1,5 veces el LSN en el momento de la selección.
    14.El paciente tiene una amputación de una extremidad inferior (sólo se acepta la amputación de uno o más dedos del pie).
    15.El paciente tiene programada una artroplastia de cadera bilateral simultánea.
    16.El paciente ha participado en otro estudio clínico de un fármaco (incluido el placebo) o un dispositivo en investigación en los 30 días previos (o el límite establecido por la legislación nacional, el periodo más largo de ambos) a la firma del consentimiento informado para el presente estudio.
    17.El paciente ha participado previamente en un ensayo clínico con YM150.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es una variable compuesta de los siguientes episodios evaluados observados hasta el día 12:
    -Trombosis venosa profunda (TVP) proximal o distal
    -TVP sintomática (proximal y distal)
    -Embolia pulmonar (EP) no mortal
    -Muerte por todas las causas
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Doble simulación
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA124
    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
    N.A.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1307
    F.4.2.2In the whole clinical trial 2000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N.A.
    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 Decision2009-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-04
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