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    Summary
    EudraCT Number:2010-020497-41
    Sponsor's Protocol Code Number:ANG.AMI-IC001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-020497-41
    A.3Full title of the trial
    A prospective, double blind, randomized, placebo-controlled clinical trial of intracoronary infusion of immunoselected, bone marrow-derived Stro3 mesenchymal precursor cells (MPC) in the treatment of patients with ST-elevation myocardial infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of allogeneic mesenchymal precursor cells (MPCs) in the treatment of heart attacks.
    A.3.2Name or abbreviated title of the trial where available
    The AMICI trial
    A.4.1Sponsor's protocol code numberANG.AMI-IC001
    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 SponsorMesoblast, Inc.
    B.1.3.4CountryUnited States
    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 supportMesoblast, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMesoblast Limited
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address5 New Street Square
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC4A 3TW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+61396396036
    B.5.6E-mailclinical@mesoblast.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 nameAllogeneic Mesenchymal Precursor Cells
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    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) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue Engineered Product; reference number: EMA/CAT/512253/2010
    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 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 nameAllogeneic Mesenchymal Precursor Cells
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    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) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue Engineered Product; Reference number: EMA/CAT/512253/2010
    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 infusion
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ST-elevation myocardial infarction
    E.1.1.1Medical condition in easily understood language
    Heart attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10064345
    E.1.2Term ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the safety and feasibility of intracoronary allogeneic, immuno-selected, bone marrow-derived Stro3 mesenchymal precursor cell (MPC) delivery in the treatment of subjects with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention of the left anterior descending coronary artery (LAD).
    E.2.2Secondary objectives of the trial
    To determine the effect of intracoronary delivery of allogeneic immunoselected, bone marrow-derived Stro3 mesenchymal precursor cells (MPC) on infarct size reduction in the treatment of subjects with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention of the left anterior descending coronary artery.

    To explore a dose-response effect of intracoronary delivered MPC in the treatment of subjects with an anterior wall STEMI on left ventricular remodelling, microvascular obstruction, and the relationship between time from onset of ischemic symptoms to primary percutaneous coronary intervention.

    To explore additional functional and clinical effects of MPC in STEMI.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be entered into this study only if they meet ALL of the following criteria:
    1. Willing and able to understand and sign the Informed Consent Form (ICF).
    2. Males or females ≥ 18 years.
    3. Clinical symptoms consistent with acute AMI (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).
    4. De novo anterior Acute Myocardial Infarct (AMI) defined as:
    ≥ 0.2 mV ST elevation in 2 or more V1 – V6 leads with presentation in a maximum of 12 hours of onset of symptoms
    Or:
    Presumed new left bundle branch block with a minimum of 0.1 mV concordant ST elevation with presentation in a maximum of 12 hours of onset of symptoms
    And:
    Occlusion or flow limiting lesion with TIMI Flow Grade 0 or 1 in the left anterior descending (LAD) coronary artery

    5. Successful revascularization of the culprit lesion in the LAD within a maximum of 12 hours from the onset of AMI symptoms defined as (1) primary percutaneous coronary intervention (PCI) with stent implantation, resulting in TIMI 3 or 2 flow AND (2) residual stenosis of less than 20% by on-line QCA.

    NOTE: Subject is eligible if in addition to requiring a primary PCI plus stenting for the culprit lesion they have a stenosis of the LAD that is both distinct from the culprit lesion and requires PCI at the time of the index cardiac catheterization procedure. For example, if the culprit lesion is in the mid LAD but there is also a high-grade first diagonal (D1) stenosis, then the latter lesion may undergo PCI (plus stenting) during the index catheterization This specifically excludes patients who may require a PCI to a non-LAD coronary artery during the index catheterization.

    6. If a female subject is of childbearing potential (i.e. not amenorrheic for 12 or more months and/or not surgically sterile), the subject must be willing to use highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS], condom occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence)) for at least 16 weeks after investigational agent infusion.

    7. Must be willing and able to return for required follow-up visits.
    E.4Principal exclusion criteria
    Subjects will not be enrolled into this study if they meet ANY of the following criteria:
    1. Prior MI, known cardiomyopathy, or hospital admission for heart failure (HF).
    2. Significant valvular disease (mitral or aortic valve regurgitation 3/4 classification as defined by ESC/ACC guidelines).
    3. Unsuccessful revascularization of culprit artery defined as TIMI 1 or 0 flow or residual diameter stenosis of ≥ 20% by on line QCA analysis.
    4. Need for staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after infusion with the investigational agent. EXCEPT: Patients who present at the index catheterization with a need for a staged PCI of a non-LAD coronary artery will be eligible if:
    -The staged PCI vessel does not have important collaterals to the LAD, and
    -Agreement from the PI that the staged PCI can be safely scheduled after the day 30 cMRI has been determined by the Core cMR Imaging Laboratory to satisfy quality-control criteria
    5. Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization,defined as the presence of any of the following:
    -Systolic blood pressure <80 mmHg lasting for more than 30 minutes
    -Heart rate >120 bpm for more than 1 hour
    6. Prior coronary artery bypass graft to LAD.
    7. History of persistent atrial fibrillation.
    8. Prior PCI involving the LAD.
    9. Malignancy within last 3 years from screening. The subject has had an active malignancy, within the past 3 years except for cervical carcinoma in situ, or non-melanoma skin cancer that has been definitively treated.
    10. Acute or chronic bacterial or viral infectious disease.
    11. Pacemaker, ICD or any other contraindication for cMRI. This is inclusive of patients with an MRI compatible device that was implanted prior to the potential qualifying event.
    12. Known history of severe chronic obstructive pulmonary Disease (Forced Expiratory Volume (FEV1) <35% in 1 second).
    13. Known glomerular filtration rate (GFR) of less than 30 mL/min at study entry.
    14. Known history of sensitization to human leukocyte antigens (such as via pregnancy, transfusions or organ transplant).
    15. Known hypersensitivity to any radiographic contrast.
    16. Known hypersensitivity to DMSO, murine proteins, bovine proteins, acetylsalicylic acid (ASA), clopidogrel, prasugrel, and/or metallic stents.
    17. Prior or current participation in any bone marrow derived autologous and allogeneic stem cell or gene therapy study.
    18. Prior participation in any other investigational drug trial in the past 30 days.
    19. Pregnant or lactating women.
    20. Intent to participate in any other investigational drug, cell or gene therapy study during the 2-year follow-up period of this study.
    21. Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility of the infusion of the investigational agent will monitored by measurement of TIMI flow and perfusion measurements prior to, during (after approximately 50% of total investigational agent volume infused) and following the investigational agent infusion after successful PCI and stenting.

    The primary safety analysis will be performed on the following safety and feasibility parameters up to 30 days post-treatment:
    - TIMI flow prior to, during (approximately 50% of total investigational agent volume infused) and following the investigational agent infusion after successful PCI.
    - Serious adverse event (SAE)/adverse event (AE) rates.
    - Results of clinical laboratory tests (including hematology, serum chemistry,
    inflammatory markers, flow cytometry anti-HLA Class I and Class II percent reactivity with specificity, antibovine and antimurine antibody analysis).
    - Infusion procedure monitoring of vital signs (heart rate, respiratory rate, BP, and temperature.

    The primary efficacy endpoint is the change in left ventricular end-systolic volume (LVESV) as assessed by cardiac MRI from baseline to 6 months post investigational agent infusion in each MPC treatment group compared with the Placebo group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary safety analysis will be assessed at 30 days post-treatment.

    The primary efficacy endpoint will be assessed at 6 months post treatment.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    •The change in LVESV as assessed by 2D-echocardiography from baseline to 6 months post investigational agent infusion.
    •The change in relative infarct size as assessed by late contrast enhancement MRI (% infarct volume/total LV tissue volume) from baseline to 6 months post investigational agent infusion
    •Additional functional efficacy endpoints will be assessed with the following diagnostic studies:
    • Cardiac MRI at 2-4 and 30 days, month 6 and 24
    - LVEF
    - LV-ESV
    - LVEDV
    - Left ventricular wall thickness and thickening in all segments including infarct area
    - Regional wall motion score
    - Myocardial MVO measured as reduced signal intensity in the region of interest
    - Myocardial salvage index
    • 2D echocardiogram at 2-4 and 30 days, months 6, 12 and 24
    - LVEF
    - Cardiac dimensions (LVESD/ LVEDD)
    - Regional wall motion score index
    •If neither MPC arm is found to be better than the placebo arm and there is no difference between the MPC groups (using the ANCOVA test with alpha=.1) in the effect on LVESV then the pooled MPC group will be compared to the placebo group for all functional parameters.
    •In addition, a subset analysis will be evaluated at the following ischemia duration time points:
    ≤2 hours
    >2 hours to ≤6 hours
    >6 to ≤12 hours
    • NT-Pro-BNP serum levels (as measurement ofbiomarker for heart failure) at baseline, days 2-4 and 30 and months 3, 6, 12, and 24
    • Score changes for TIMI Flow Grade and Perfusion assessments at the following day 0 time points:
    - pre-PCI,
    - immediately post-PCI,
    - after approximately 50% of intracoronary infusion of investigational agent,
    - at completion of intracoronary infusion of investigational agent.

    Safety endpoints:
    Serious adverse events (SAEs) / adverse events (AEs) rates
    - Occurrence of MACCE including:
    o Cardiovascular death,
    o Non-fatal myocardial infarction
    o Non-fatal stroke
    o Cardiac hospitalization due to heart failure
    - Target vessel (or other vessel) revascularization, post index cardiac catheterization and new or worsening heart failure during the index hospitalizationwill be tracked as “Adverse Events of Special Interest”.
    - Total number of subjects with documented ventricular arrhythmia (sustained and non-sustained VT/VF) throughout the study period.
    - Angina pectoris as defined by Canadian Cardiovascular Society (CCS) clinical clarification .
    - New York Heart Association (NYHA) Class.
    - Telemetry/48 hour Holter monitoring (during hospital admission and at 14 and 30 days, 3 and 6 months follow-up time points) with assessment of occurrence of ventricular arrhythmia.
    - TIMI flow and perfusion measurements following intracoronary infusion of the MPC cell solution compared with placebo.
    - Physical examinations, monitoring of vital signs (heart rate, respiratory rate, BP, and oral temperature
    - Results of clinical laboratory tests (hematology, serum chemistry, inflammatory markers), and immunogenicity assays; (flow cytometry Class I and Class II HLA percent reactivity % with specificity, antibovine and antimurine antibody analysis).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Endpoints:
    • Cardiac MRI at 2-4 and 30 days, month 6 and 24
    • 2D echocardiogram at 2-4 and 30 days, months 6, 12 and 24
    •Subset analysis will be evaluated at the following ischemia duration time points:
    ≤2 hours
    >2 hours to ≤6 hours
    >6 to ≤12 hours
    • NT-Pro-BNP serum levels (as measurement ofbiomarker for heart failure) at baseline, days 2-4 and 30 and months 3, 6, 12, and 24
    • Score changes for TIMI Flow Grade and Perfusion assessments.

    Safety endpoints: up to 24 months post treatment.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) 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.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Czech Republic
    Denmark
    Netherlands
    New Zealand
    Poland
    Portugal
    Spain
    Sweden
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 105
    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
    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 Decision2011-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
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