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    Summary
    EudraCT Number:2006-006656-35
    Sponsor's Protocol Code Number:A3711047
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-03
    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 number2006-006656-35
    A.3Full title of the trial
    "A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled
    Estimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 in
    the Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With and
    Without Erectile Dysfunction (ED)"

    "Estudio estimativo multicéntrico, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo para valorar la eficacia y la seguridad de UK 369,003 de liberación modificada en el tratamiento de varones con síntomas del tracto urinario inferior (STUI) relacionados con el llenado, con y sin disfunción eréctil (DE)"
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberA3711047
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorPFIZER
    B.1.3.4CountrySpain
    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 nameUK-369,003-besilato
    D.3.4Pharmaceutical form Modified-release 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.3.9.1CAS number 334827-98-4
    D.3.9.2Current sponsor codeUK-369,003
    D.3.9.3Other descriptive nameUK-369,003-besilato
    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 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 nameUK-369,003-besilato
    D.3.4Pharmaceutical form Modified-release 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.3.9.1CAS number 334827-98-4
    D.3.9.2Current sponsor codeUK-369,003
    D.3.9.3Other descriptive nameUK-369,003-besilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 nameUK-369,003-besilato
    D.3.4Pharmaceutical form Modified-release 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.3.9.1CAS number 334827-98-4
    D.3.9.2Current sponsor codeUK-369,003
    D.3.9.3Other descriptive nameUK-369,003-besilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameUK-369,003-besilato
    D.3.4Pharmaceutical form Modified-release 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.3.9.1CAS number 334827-98-4
    D.3.9.2Current sponsor codeUK-369,003
    D.3.9.3Other descriptive nameUK-369,003-besilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Síntomas del tracto urinario inferior (STUI) relacionados con el llenado en varones con y sin disfunción eréctil (DE).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10046566
    E.1.2Term Urinary tract disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimar la eficacia de UK 369,003 MR frente a placebo en el tratamiento de los STUI de llenado en varones con y sin DE
    E.2.2Secondary objectives of the trial
    •Evaluar la seguridad y la tolerabilidad de UK 369,003 en varones con STUI de llenado, con y sin DE.

    •Describir la relación entre dosis y respuesta de UK 369,003 en varones con STUI de llenado con y sin DE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones mayores de 18 años, con diagnóstico clínico de VHA, documentado y verificado mediante el diario de STUI, que se define como:
    • Frecuencia urinaria media ≥8 veces/24 horas.
    • Número medio de episodios de urgencia, con o sin incontinencia de urgencia ≥1 episodio/24 horas.
    2. Volumen medio evacuado <300 ml, verificado mediante el diario de micciones rellenado antes de la aleatorización.
    3. Qmáx >5 ml/s con un volumen evacuado >150 ml.
    4. Pareja sexual estable mientras dure el ensayo.
    5. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, en el que se indique que el sujeto (o su representante legal) ha sido informado de todos los aspectos pertinentes del ensayo.
    6. Disposición y capacidad del sujeto para cumplir las visitas programadas, los planes de tratamiento, los análisis clínicos y otros procedimientos del ensayo.
    E.4Principal exclusion criteria
    1. Antecedentes, demostración o sospecha de cáncer de próstata en la visita de selección o durante el ensayo.
    2. Volumen residual posmiccional >200 ml según la ecografía vesical obtenida en la visita de selección.
    3. Infección urinaria (IU) documentada en la visita de selección;
    4. Hematuria superior a 1+ en el análisis de orina con tira reactiva en la visita de selección,
    5. Antecedentes de intervención quirúrgica o procedimientos urológicos relevantes que puedan contribuir a los STUI.
    6. Enfermedad local persistente crónica del tracto urinario inferior.
    7. Trastorno neurológico primario conocido u otras enfermedades neurológicas que afecten a la función vesical.
    8. Antecedentes de sondaje por obstrucción del flujo de salida en los 12 meses previos a la visita de selección.
    9. Empleo de cualquier forma de electroestimulación o de ejercicios para la vejiga en los últimos 30 días o previsión de comenzar dicho tratamiento durante el estudio.
    10. Sujetos con un volumen total evacuado >3.000 ml como promedio en 24 horas, confirmado mediante el diario de STUI rellenado antes de la aleatorización.
    11. Sujetos que reciban o tengan probabilidades de recibir cualquiera de los siguientes medicamentos o tratamientos durante el período del ensayo:
    • Alfabloqueantes, antagonistas de los receptores muscarínicos, inhibidores de la PDE5 y fármacos que afecten a la función vesico uretral o a la función eréctil. Dichos tratamientos deben interrumpirse al menos 4 semanas antes de la aleatorización de la visita basal.
    • I5 α R (a menos que la dosis fuera estable en los 6 meses previos a la aleatorización de la visita basal y que se mantenga estable mientras dure el ensayo).
    • Diuréticos, betabloqueantes u otros antihipertensivos (a menos que la dosis fuera estable en las cuatro semanas previas a la visita 3 (basal) y que se mantenga estable mientras dure el ensayo).
    • Nitratos o donantes de óxido nítrico en cualquier forma, administrados con regularidad o de manera intermitente.
    • Inhibidores potentes de la CYP3A4. Se permite el uso de fármacos tópicos.
    • Warfarina.
    12. Alergia importante o hipersensibilidad conocida o intolerancia a los inhibidores de la PDE5 o a cualquiera de los excipientes de la formulación.
    13. Aumento de la sensibilidad a los vasodilatadores, incluidos los sujetos con obstrucción del flujo de salida del ventrículo izquierdo.
    14. Diabetes mellitus de tipo I o II mal controlada.
    15. Pérdida de la visión en un ojo debido a neuropatía óptica isquémica no arterítica (NOINA).
    16. Trastornos retinianos degenerativos hereditarios.
    17. Antecedentes de síncope recurrente o demostración de presión arterial (PA) baja o demostración de hipotensión postural sintomática.
    18. Cualquier anomalía relevante y clínicamente significativa en la exploración física o en las pruebas analíticas de la visita de selección.
    19. Antecedentes familiares de síndrome de QT prolongado o que presenten un QTc >450 ms en la visita 1.
    20. Riesgo de priapismo.
    21. Sujetos que, en la actualidad, experimentan cualquier trastorno médico clínicamente significativo o inestable que pueda limitar su capacidad de completar el ensayo.
    22. Cualquier trastorno maligno que no se considere curado (excepto el carcinoma basocelular de la piel). Los antecedentes de cáncer de vejiga o de próstata son motivo de exclusión independientemente de la situación actual.
    23. Donación de sangre en las 4 semanas previas a la visita 1 (selección), o intención declarada de donar sangre o hemoderivados durante el período del ensayo o en el mes siguiente a la última visita prevista.
    24. Sujetos que, en opinión del investigador, abusen del alcohol o de las drogas o que tengan pocas probabilidades de completar el ensayo por las razones que sean.
    25. Sujetos que hayan recibido cualquier fármaco de investigación en los 30 días previos a la visita de selección o en el período correspondiente a cinco veces la semivida plasmática (si se conoce), lo que suponga más tiempo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Diario de STUI:
    a. Volumen de micción medio.
    b. Frecuencia de episodios de urgencia.
    c. Intensidad de los episodios de urgencia
    d. Frecuencia de micciones.
    e. Frecuencia de micción normalizada (FMN)
    f. Frecuencia de episodios de incontinencia.
    g. Episodios de micción asociados a urgencia
    h. Frecuencia nocturna.
    2. Puntuación internacional de síntomas prostáticos (IPSS)
    3. Cuestionario sobre la vejiga hiperactiva, versión breve (OAB q SF)
    4. Percepción por el paciente del trastorno vesical (PPBC)
    5. Cuestionario internacional sobre la incontinencia – síntomas del tracto urinario inferior en varones (ICIQ MLUTS)
    6. Dominio de la función eréctil (FE) del índice internacional de la función eréctil (IIEF)
    7. Cuestionario sobre la calidad de la erección (QEQ)
    8. Cuestionario del efecto del tratamiento comunicado por el paciente (PRTI)
    9. Farmacocinética de población.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 No
    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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 350
    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 Decision2007-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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