Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-003018-11
    Sponsor's Protocol Code Number:CQGE031E12301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 number2020-003018-11
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para investigar la eficacia y la seguridad de ligelizumab (QGE031) en el tratamiento de la urticaria crónica inducible (CINDU) en adolescentes y adultos inadecuadamente controlados con antihistamínicos H1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of ligelizumab in adolescents and adults with chronic inducible urticaria who remain symptomatic despite treatment with H1- antihistamines
    Estudio de eficacia y seguridad de ligelizumab en adolescentes y adultos con urticaria crónica inducible que continúen presentando síntomas a pesar del tratamiento con antihistamínicos H1.
    A.4.1Sponsor's protocol code numberCQGE031E12301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica S.A.
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.com
    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 nameLigelizumab
    D.3.2Product code QGE031
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNLIGELIZUMAB
    D.3.9.2Current sponsor codeQGE031
    D.3.9.3Other descriptive nameAnti-IgE antibody
    D.3.9.4EV Substance CodeSUB177843
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboSolution for injection
    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
    Chronic Inducible Urticaria
    Urticaria Crónica Inducible (CINDU)
    E.1.1.1Medical condition in easily understood language
    Chronic Hives
    Habones crónicos
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009869
    E.1.2Term Cold urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008675
    E.1.2Term Cholinergic urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10012521
    E.1.2Term Dermographism
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to a standardized provocation test for each CINDU subtype.
    Demostrar la superioridad de ligelizumab frente a placebo en relación con el cambio respecto a la basal en respuesta a la prueba de provocación estandarizada en cada subtipo de UCI.
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of ligelizumab versus placebo with regard to proportion of participants with a complete response after standardized provocation test.
    To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation test.
    To assess the safety of ligelizumab.
    Demostrar la superioridad de ligelizumab frente a placebo respecto a la proporción de participantes con respuesta completa después de la prueba de provocación estandarizada.
    Demostrar la superioridad de ligelizumab frente a placebo en la escala numérica del picor tras la prueba de provocación.
    Evaluar la seguridad de ligelizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained before any assessment is performed.
    2. Participant’s parent’s or legal guardian’s signed informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed.
    3. Male and female participants >=12 years of age at the time of screening.
    4. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for >= 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)).
    5. Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization
    6. Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
    7. Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
    8. Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules.
    1. Se debe obtener el consentimiento informado firmado antes de realizar cualquier evaluación.
    2. Se deberá obtener el consentimiento informado firmado por parte
    sus progenitores o tutor legal del participante y el asentimiento del niño, si procede, antes de realizar
    cualquier evaluación.
    3. Participantes de ambos sexos de >=12 años de edad en el momento de la selección.
    4. Diagnóstico de CINDU confirmado (según las guías) de dermografismo
    sintomático, urticaria por frío o urticaria colinérgica durante >= 4 meses (definido como
    la aparición de CINDU con documentación de apoyo (p. ej., historia clínica,
    antecedentes clínicos o fotografías)).
    5. Diagnóstico de CINDU (dermografismo sintomático, urticaria por frío o urticaria
    colinérgica) inadecuadamente controlada con dosis de antihistamínicos H1
    autorizadas en la ficha técnica local en el momento de la aleatorización.
    6. Los participantes deben realizar físicamente la prueba de provocación específica
    definida en el protocolo para los participantes con CINDU.
    7. Los participantes con urticaria colinérgica deben sudar al realizar la prueba de
    ergometría controlada por el pulso el día de la aleatorización. No se deben incluir
    participantes con anhidrosis.
    8. Voluntad y capacidad para cumplimentar un diario electrónico con los síntomas
    experimentados a diario según el requisito del protocolo y seguir el calendario de
    visitas del estudio.
    E.4Principal exclusion criteria
    1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days for small molecules prior to the screening visit or until the expected pharmacodynamic effect has returned to baseline for biologics, whichever is longer.
    2. History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests
    3. Participants who have any concomitant CSU at screening
    4. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study
    5. Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
    6. Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
    7. Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
    8. Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies
    9. Female participants, including adolescent females of 12 to less than 18 years of age, of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
    1. Uso de cualquier otro fármaco en investigación en un plazo de 5 vidas medias antes del reclutamiento o durante los 30 días anteriores a la visita de selección, en caso de moléculas pequeñas, o hasta que el efecto farmacodinámico previsto vuelva a los valores basales, en caso de productos biológicos; aquel periodo que sea más largo.
    2. Antecedentes de hipersensibilidad a cualquiera de los fármacos del estudio o a sus componentes, a fármacos de clases similares (es decir, a anticuerpos murinos, quiméricos o humanos), a la prueba de provocación o a objetos que se utilizan en las pruebas de provocación.
    3. Participantes con UCE concomitante en la selección.
    4. Participantes con una forma familiar (p. ej., síndrome familiar autoinflamatorio por frío o urticaria familiar por frío) de la UCI específica que se considere para la inclusión del participante en este estudio.
    5. Participantes con otra forma de urticaria inducible más definida que la UCI específica que se considere para la inclusión del participante en este estudio.
    6. Enfermedades, salvo la urticaria crónica inducible, con síntomas de urticaria o angioedema como vasculitis urticarial, eritema multiforme, mastocitosis cutánea (urticaria pigmentosa) y angioedema hereditario o adquirido (p. ej., debido a una deficiencia del inhibidor C1).
    7. Cualquier otra enfermedad cutánea asociada a picazón crónica que pudiera influir, en opinión del investigador, en las evaluaciones y los resultados del estudio (p. ej., dermatitis atópica, penfigoide bulloso, dermatitis herpetiforme, prurito senil, etc.) o enfermedades cutáneas asociadas solo a ronchas y no a picor, p. ej., dermografismo asintomático.
    8. Exposición anterior a ligelizumab, omalizumab u otros tratamientos anti-IgE.
    9. Participantes, incluidas las adolescentes entre 12 y 18 años de edad, en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que esté utilizando métodos anticonceptivos efectivos durante la administración del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic Dermographism
    Change from baseline in Total Fric Score (TFS) at Week 12 in response to FricTest® 4.0
    Cold Urticaria
    Change from baseline in critical temperature threshold (CTT) at Week 12 in response to the TempTest® 4.0
    Cholinergic Urticaria
    Change from baseline in itch numerical rating scale (NRS) at Week 12 in response to the pulse-controlled ergometry test.
    Dermografismo sintomático.
    Cambio respecto a la basal en la puntuación total de la prueba de Fric (TFS) en la semana 12 en la respuesta a la FricTest® 4.0.
    Urticaria por el frío.
    Cambio respecto a la basal en el umbral crítico de temperatura (CTT) en la semana 12 en la respuesta a la TempTest® 4.0.
    Urticaria colinérgica.
    Cambio respecto a la basal en la escala numérica del picor en la semana 12 en la respuesta a la prueba de ergometría controlada por el pulso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Symptomatic Dermographism
    Proportion of participants with complete response in FricTest® at Week 12

    Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline

    Cold Urticaria
    Proportion of participants with complete response in TempTest® at Week 12
    Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS > 0 at baseline

    Cholinergic Urticaria
    Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 12
    Proportion of participants with physician global assessment of severity of hives=0 following the pulse-controlled ergometry test at Week 12

    Safety endpoints will include but not be limited to:
    •Occurrence of treatment emergent adverse events (serious and non-serious) during the study
    •Occurrence of treatment emergent adverse events during the study leading to discontinuation of study treatment
    •Occurrence of treatment emergent adverse events of interest listed as either identified or potential risks, during the study
    •Changes in safety parameters
    Dermografismo sintomático.
    Proporción de participantes con una respuesta completa en la FricTest® en la semana 12.
    Cambio respecto a la basal en la escala numérica del picor tras la prueba de provocación en la semana 12, en participantes con un valor >0 en la escala numérica del picor de la basal.
    Urticaria por el frío.
    Proporción de participantes con una respuesta completa en la TempTest® en la semana 12.
    Cambio respecto a la basal en la escala numérica del picor tras la prueba de provocación en la semana 12, en participantes con un valor >0 en la escala numérica del picor de la basal.
    Urticaria colinérgica.
    Proporción de participantes con un valor = 0 en la escala numérica del picor tras la prueba de ergometría controlada por el pulso en la semana 12.
    Proporción de participantes con una evaluación médica global de la gravedad de los habones = 0 después de la prueba de ergometría controlada por el pulso en la semana 12.
    Las variables de seguridad incluirán, entre otros:
    -Aparición de acontecimientos adversos (graves y no graves) con el tratamiento durante el estudio.
    -Aparición de acontecimientos adversos con el tratamiento durante el estudio que conlleven la discontinuación del tratamiento del estudio.
    -Aparición de acontecimientos adversos de interés con el tratamiento durante el estudio, que se hayan identificado como riesgos o que sean posibles riesgos.
    -Cambios en los parámetros de seguridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 Weeks and over time
    En la semana 12 y a lo largo del tiempo.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To assess immunogenicity (IG) of ligelizumab
    Evaluar la inmunogenicidad (IG) de ligelizumab
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 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.8.2.4Number of treatment arms in the trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Chile
    China
    India
    Israel
    Jordan
    Korea, Republic of
    Lebanon
    Malaysia
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Turkey
    United States
    Vietnam
    Austria
    Bulgaria
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Slovakia
    Slovenia
    Spain
    United Kingdom
    Argentina
    Greece
    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
    LVLS
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 22
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 325
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 428
    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)
    Participants may be eligible for post-trial access after completion of the study
    Los participantes podrían ser elegibles para un acceso posterior al ensayo tras la finalización del estudio.
    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 Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-09
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 01 11:02:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA