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   43874   clinical trials with a EudraCT protocol, of which   7294   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:2019-004947-65
    Sponsor's Protocol Code Number:IMPACT-TDM
    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:2021-09-01
    Trial 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 number2019-004947-65
    A.3Full title of the trial
    IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS
    IMPACTO EN LOS RESULTADOS CLÍNICOS Y EN EL COSTE-EFECTIVIDAD DEL PROGRAMA DE MONITORIZACIÓN TERAPÉUTICA DE ANTIMICROBIANOS EN PACIENTES CRÍTICOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS
    IMPACTO EN LOS RESULTADOS CLÍNICOS Y EN EL COSTE-EFECTIVIDAD DEL PROGRAMA DE MONITORIZACIÓN TERAPÉUTICA DE ANTIMICROBIANOS EN PACIENTES CRÍTICOS
    A.4.1Sponsor's protocol code numberIMPACT-TDM
    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 SponsorSantiago Grau Cerrato
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFondo de Investigación en Salud. Instituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSantiago Grau Cerrato
    B.5.2Functional name of contact pointSantiago Grau Cerrato
    B.5.3 Address:
    B.5.3.1Street AddressMarítim de la Barceloneta, 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number34922483154
    B.5.5Fax number34922483256
    B.5.6E-mailsgrau@parcdesalutmar.cat
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLinezolid
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinezolid
    D.3.9.1CAS number 165800-03-3
    D.3.9.3Other descriptive nameLINEZOLID
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 8
    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) 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.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMeropenem
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeropenem
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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.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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLinezolid
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinezolid
    D.3.9.1CAS number 165800-03-3
    D.3.9.3Other descriptive nameLINEZOLID
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) 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.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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMeropenem
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeropenem
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Respiratory infections
    - Urogenital infections
    - Abdominal infections
    Infección bacteriana de foco respiratorio, urológico o abdominal
    E.1.1.1Medical condition in easily understood language
    - Respiratory infections
    - Urogenital infections
    - Abdominal infections
    Infección bacteriana de foco respiratorio, urológico o abdominal
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10056570
    E.1.2Term Intra-abdominal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038700
    E.1.2Term Respiratory infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10065583
    E.1.2Term Urogenital infection bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of the implementation of an antimicrobial therapeutic monitoring program in the reduction of days until clinical cure compared to the usual management of antibiotic therapy without a therapeutic monitoring program.
    Evaluar el impacto de la implementación de un programa de monitorización terapéutica de antimicrobianos en la reducción de días hasta la curación clínica frente al manejo habitual de la terapia antibiótica sin programa de monitorización terapéutica.
    E.2.2Secondary objectives of the trial
    a. To determine the cost-effectiveness of a Linezolid and Meropenem monitoring program in critically ill patients.
    b. To evaluate the stay in the ICU and the hospital stay between both treatment arms.
    c. Evaluate crude mortality and 30-day mortality between both treatment arms.
    d. To evaluate the proportion of patients who achieve an optimal PK / PD index for each antibiotic in each of the treatment arms.
    and. Identify the profile of patients and the type of infection that can benefit the most from dose monitoring programs
    F. To assess the frequency of medication-related toxicity and adverse events between the two treatment arms.
    a. Determinar el coste-efectividad de un programa de monitorización de Linezolid y Meropenem en pacientes críticos.
    b. Evaluar la estancia en UCI, y la estancia hospitalaria entre ambas ramas de tratamiento.
    c. Evaluar la mortalidad cruda y la mortalidad a treinta días entre ambas ramas de tratamiento.
    d. Evaluar la proporción de pacientes que alcanzan un índice PK/PD óptimo para cada antibiótico en cada una de las ramas de tratamiento.
    e. Identificar el perfil de pacientes y el tipo de infección que se pueden beneficiar más de los programas de monitorización de dosis
    f. Evaluar la frecuencia de toxicidad relacionada con la medicación y los acontecimientos adversos entre las dos ramas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of both sexes over 18 years of age
    2. Patients admitted to intensive care units with suspected or confirmed bacterial infection of respiratory, urological or abdominal focus
    3. Patients being treated with linezolid, meropenem alone or in combination with each other, for at least 72 hours
    1. Pacientes de ambos sexos mayores de 18 años de edad
    2. Pacientes ingresados en las unidades de cuidados intensivos con sospecha o confirmación de infección bacteriana de foco respiratorio, urológico o abdominal
    3. Pacientes en tratamiento con linezolid, meropenem en monoterapia o combinados entre sí, durante al menos 72 horas.
    E.4Principal exclusion criteria
    1. Pregnant or actively breastfeeding patients.
    2. Patients receiving oral linezolid
    3. Patients undergoing treatment with any renal replacement therapy or extracorporeal support.
    1. Pacientes embarazadas o en periodo de lactancia activa.
    2. Pacientes en tratamiento con linezolid oral
    3. Pacientes en tratamiento con cualquier terapia renal sustitutiva o soporte extracorpóreo.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response
    - Clinical healing. Disappearance of ALL symptoms and signs of infection present before starting treatment.
    - Failure. Symptoms and signs of infection present before starting treatment do not change or worsen)
    - Recurrence. Improvement or disappearance of symptoms and signs of infection present before starting treatment with subsequent reappearance or worsening during follow-up.
    Respuesta clínica
    - Curación clínica. Desaparición de TODOS los síntomas y signos de infección presentes antes de iniciar el tratamiento.
    - Fracaso. No se modifican o empeoran los síntomas y signos de infección presentes antes de iniciar el tratamiento )
    - Recurrencia. Mejoría o desaparición de los síntomas y signos de infección presentes antes de iniciar el tratamiento con posterior reaparición o empeoramiento durante el seguimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 30 days
    At ICU discharge
    At hospital discharge
    A los 30 días
    Al alta de UCI
    Al alta hospitalaria
    E.5.2Secondary end point(s)
    Microbiological response
    - Eradication. Absence of growth of the causative microorganism present before starting treatment.
    - Persistence Isolation of the same microorganism after completing the treatment without having achieved eradication.
    - Recurrence Isolation of the same microorganism after completing the treatment after having reached an apparent eradication,
    - Superinfection Isolation of a pathogenic microorganism different from the causative agent of the original infection.
    Respuesta microbiológica
    - Erradicación. Ausencia de crecimiento del microorganismo causal presente antes de iniciar el tratamiento.
    - Persistencia Aislamiento del mismo microorganismo tras completar el tratamiento sin haber alcanzado la erradicación.
    - Recurrencia Aislamiento del mismo microorganismo tras completar el tratamiento tras haber alcanzado una aparente erradicación,
    - Superinfección Aislamiento de un microorganismo patógeno diferente al agente causal de la infección original.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 days
    At ICU discharge
    At hospital discharge
    A los 30 días
    Al alta de UCI
    Al alta hospitalaria
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    Regimen de dosificación autorizado
    Authorized dose regimen
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 de último paciente incluido
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 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 state230
    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)
    None
    No
    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 Decision2021-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
    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 15 23:08:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA