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    Summary
    EudraCT Number:2008-008198-73
    Sponsor's Protocol Code Number:CR-AIR-004
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-12
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-008198-73
    A.3Full title of the trial
    An open-label, uncontrolled, multicenter, multinational study on the efficacy and safety of administration of donor lymphocytes depleted of alloreactive T-cells (ATIR), through the use of TH9402 and light treatment in an ex vivo process, in patients receiving a CD34-selected peripheral blood stem cell graft from a related, haploidentical donor.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational and multicentre clinical trial, in which researchers and participants are informed of applied treatment. This study compares the safety and efficacy of ATIR, donor lymphocytes deleted for T cells pertaining to the immune response in reaction to transplanted cells through the use of photosynthesis and light treatment before transferring them to patients receiving transplant from a related donor, sharing the same allele at a set of linked genes.
    A.4.1Sponsor's protocol code numberCR-AIR-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00967343
    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 SponsorKiadis Pharma Netherlands B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPHARMACELL BV
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportKiadis Pharma Netherlands B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaCell BV
    B.5.2Functional name of contact pointDirector Quality Assurance
    B.5.3 Address:
    B.5.3.1Street AddressOxfordlaan 70
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 EV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+ 314335 09910
    B.5.5Fax number+ 314336 19732
    B.5.6E-mailinfo@pharmacell.nl
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/561
    D.3 Description of the IMP
    D.3.1Product nameATIR
    D.3.2Product code ATIR
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Patients with hematologic malignancies who are eligible for an allogeneic stem cell transplantation but without the availability of an (according to the treating physician) suitable matched related or unrelated donor following a donor search.
    E.1.1.1Medical condition in easily understood language
    Patients with an abnormal growth of cells rising through transformation of bone marrow derived cells that are eligible for HSCT, but have no suitable matched related family or unrelated donor.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10066110
    E.1.2Term T-cell lymphoblastic leukemia acute
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10028233
    E.1.2Term Multiple myeloma without mention of remission
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10028578
    E.1.2Term Myeloproliferative disorders (excl leukaemias)
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10025310
    E.1.2Term Lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10000887
    E.1.2Term Acute myeloid leukemia in remission
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008948
    E.1.2Term Chronic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10063625
    E.1.2Term Acute lymphoblastic leukemia recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effects of the administration of a donor lymphocyte preparation selectively depleted of host alloreactive T-cells (ATIR) to patients with hematologic malignancies on 6 months and 12 months TRM.
    E.2.2Secondary objectives of the trial
    • To study the effects of ATIR on Overall Survival (OS).
    • To study the effects of ATIR on the incidence and severity of acute GvHD.
    • To study the effects of ATIR on the incidence and severity of chronic GvHD.
    • To study the effects of ATIR on Progression Free Survival (PFS).
    • To study the effects of ATIR on the incidence and severity of bacterial, viral or fungal infections.
    • To study the effects of ATIR on immune reconstitution.
    • To study the effects of ATIR on the health status of patients (including Quality of Life [QoL]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must comply with the recipient inclusion and exclusion criteria mentioned below. These criteria must be assessed before patient apheresis.
    Recipient Inclusion Criteria (any of the following)
    Initially, both patients with primary and secondary indications are eligible for the trial. During the trial accrual may be limited to the primary indications based on a recommendation made by the Independent Data Monitoring Committee (IDMC).
    • Acute Myeloid Leukemia (AML): AML in first remission with high risk features (secondary AML, FLT-3 mutation, complex karyotype, abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), or other cytogenetic anomaly of similar poor prognosis, or need for 2 induction regimens to achieve a complete remission (CR)). All AML in second remission.
    Group 1: Primary Indications
    • Acute Lymphoblastic Leukemia (ALL): ALL in first remission with high-risk features (presenting leukocyte count > 30,000/mm3 for B-cell ALL or > 100,000/mm3 for T-cell ALL, karyotypes t(9;22), t(11;19), and t(4;11) biphenotypic leukemia, pro-B-ALL, late CR after induction therapy, rising MRD markers). All ALL in second remission.
    • Myelodysplastic Syndrome (MDS): Transfusion-dependent MDS with low or intermediate-1 IPSS score, and all MDS with intermediate-2 or high IPSS score. Patients with more than 20% blasts in the marrow will be considered AML.
    • Ph-positive chronic myeloid leukemia (CML): Patients with Ph-positive CML in first chronic phase who have failed (either resistant or intolerant) at least 2 tyrosine kinase inhibitors and any patient with the T315I mutation (irrespective of prior tyrosine kinase inhibitors).

    Group 2: Secondary Indications
    AML:
    - All AML not belonging to Group 1 in subsequent remission or with evidence of chemo-sensitive disease or,
    - Patients requiring 3 or more induction regimens to achieve a first remission or,
    - Patients with AML in hematologic remission who relapsed more than 2 years after allogeneic stem cell transplantation.
    • ALL: All ALL not belonging to Group 1 in subsequent remission or with evidence of chemo-sensitive disease. Patients with ALL in hematologic remission who relapsed more than 2 years after allogeneic stem cell transplantation.
    • Non-Hodgkin Lymphoma (NHL): All high grade and low grade Non-Hodgkin lymphoma (other than CLL and MM) in 2nd or 3rd remission (at least PR) after standard of care treatments including autologous stem cell transplantation.
    • Chronic Myeloid Leukemia (CML): Patients with accelerated phase CML or CML in second or later chronic phase.
    • Multiple Myeloma (MM): Secretory MM with or without osteolytic lesions concurrently not featuring extramedullary disease responsive to prior autologous stem cell transplantation(s) or at least one standard of care treatment (defined as 50% reduction of paraprotein in serum/plasma and/or 75% reduction of paraprotein in urine).
    • Chronic Lymphocytic Leukemia (CLL):
    - CLL non-responsive or early relapsed (within 12 months) after a previous fludarabine- or equivalent purine-based regimen or,
    - CLL relapsed (within 24 months) after purine analogue combination therapy or treatment of similar efficacy (i.e. autologous stem cell transplantation) or,
    - CLL with p53 deletion/mutation (i.e. del 17p-) requiring treatment.
    • CLL transformed to high grade lymphoma (Richter transformation) having demonstrated at least PR.
    • MPS: Myeloproliferative disorders in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia including atypical (Ph negative) chronic myeloid and neutrophilic leukemias, and progressing myelofibrosis. Patients with more than 20% blasts in the marrow will be considered AML.

    Other inclusion criteria:

    • Male or female, age ≥ 18, ≤ 65 years.
    • Ability to comprehend the investigational nature of the study and provide informed consent.

    Donor inclusion criteria:

    • Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype.
    • Male or female, age ≥ 16, ≤ 75 years.
    • Donors must be fit to receive G-CSF and undergo apheresis (normal blood count, normotensive and no history of stroke).
    • Donor must have Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
    • Donor must provide written informed consent.

    E.4Principal exclusion criteria
    Recipient exclusion criteria (any of the following):

    • AML in 1st CR with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21).
    • MM featuring concurrent extramedullary disease or being non-responsive to prior therapy
    • CML in blast crisis.
    • CLL concurrently transformed into high-grade lymphoma and failing to demonstrate at least PR.
    • NHL with concurrent bulky disease (≥ 5 cm).
    • Diffusing Capacity for Carbon Monoxide (DLCO) < 40% predicted.
    • Left ventricular ejection fraction < 40% (evaluated by echocardiogram or MUGA).
    • AST/SGOT > 2.5 x ULN (CTCAE grade II v3.0).
    • Bilirubin > 1.5 x ULN (CTCAE grade II v3.0).
    • Creatinine > 1.5 x ULN (CTCAE grade II v 3.0).
    • HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation).
    • Positive pregnancy test for women of childbearing age.
    • Prior haploidentical PBSC or cord blood transplantation.
    • Less than 2 years from a prior allogeneic stem cell transplantation.
    • Estimated probability of surviving less than three months.
    • Major anticipated illness or organ failure incompatible with survival from transplant.
    • Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
    • Known allergy to any of the components of ATIR (e.g., dimethyl sulfoxide).
    • Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study.

    Donor exclusion criteria:

    • Medically uncontrolled coronary heart disease.
    • Myocardial infarction within the last 3 months.
    • History of uncontrolled seizures.
    • History of malignancy (except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up).
    • Positive test result for any of the mandatory viral tests in the applicable region, except for a positive cytomegalovirus (CMV) result, which does not lead to exclusion.
    • Presence of a transmissible disease (such as HIV positive), a major illness, a suspected systemic dysfunction and/or an active inflammatory or autoimmune disorder.
    • Female donors who are pregnant or nursing.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of TRM at 6 months and 12 months after the transplantation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence of TRM at 6 and 12 months after the transplantation. Time to TRM will be calculated from the date of receipt of the HSCT.
    E.5.2Secondary end point(s)
    • Overall Survival (OS).
    • Incidence and severity of acute and chronic GvHD.
    • Progression free survival (PFS).

    • The incidence, severity and duration of fungal, viral and bacterial infections occurring within the first year following HSCT.

    • Immune reconstitution.

    • To measure the health status of patients, the EQ-5D and the Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT) will be used.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be assessed weekly for the first 100 days after the transplant. Patients will be assessed every month up to 6 months after the transplantation, every 2 months up to 12 months after the transplantation and subsequently every 3 months up to 24 months after the transplantation. Patients will be followed-up for 24 months to assess overall survival.
    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 No
    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.6.13.1Other scope of the trial description
    Cellular therapy using haploidentiacl donor lymphocytes, selectively eliminated for alloreactive T cells through using the photosensitizing compound TH9402, resulting in the cellular product ATIR.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    External control groups are described in detail in a separate protocol (CR-AIR-006).
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Belgium
    Canada
    France
    Germany
    United Kingdom
    United States
    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
    A total of up to 70 patients are expected to be treated with ATIR™, in order to obtain at least 60 evaluable patients. Patients who die due to progression or replace prior to 6 or 12 months will not be considered evaluated and will be replaced. The trial ends when the last enrolled patient has completed the last follow up visit (24 months after the transplantation), or earlier if the last patient dropped out before the last follow up visit could be performed.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 70
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 70
    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)
    Since treatment being studied is only administered once, treatment or care after the patient has ended his/her participation in the trial is not different from the expected normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-07
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