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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-002250-24
    Sponsor's Protocol Code Number:GCAR-7213
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002250-24
    A.3Full title of the trial
    An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
    Studio internazionale, senza soluzione di continuità di fase II/III con piattaforma di randomizzazione adattiva alla risposta per valutare più regimi nel glioblastoma (GBM) di nuova diagnosi e ricorrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
    Studio progettato per valutare più regimi nel glioblastoma appena diagnosticato e ricorrente (GBM)
    A.3.2Name or abbreviated title of the trial where available
    GBM AGILE: Glioblastoma Adaptive Global Innovative Learning Environment
    GBM AGILE: ambiente di apprendimento innovativo globale adattivo del glioblastoma
    A.4.1Sponsor's protocol code numberGCAR-7213
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03970447
    A.5.4Other Identifiers
    Name:IND NumberNumber:128245
    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 SponsorGlobal Coalition for Adaptive Research
    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 supportGlobal Coalition for Adaptive Research
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA Biotech
    B.5.2Functional name of contact pointSenior Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address59 Forest Oaks Drive
    B.5.3.2Town/ cityMorrisville, NC
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+9193348749
    B.5.6E-mailjill.hutchinson@iqvia.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 Yes
    D.2.1.1.1Trade name STIVARGA
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSTIVARGA (Regorafenib)
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGORAFENIB
    D.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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
    Oncology - Glioblastoma (GBM)
    Oncologia - Glioblastoma (GBM)
    E.1.1.1Medical condition in easily understood language
    Malignant brain tumour
    Tumori cerebrali maligni
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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 identify experimental therapies that improve overall survival (OS) for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment.

    • To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
    1. Identificare le terapie sperimentali che migliorano la sopravvivenza complessiva (OS) per i pazienti con GBM nella fase di screening (Fase 1), stabilendo se i sottotipi di pazienti predefiniti o i biomarcatori associati traggano un beneficio unico dal trattamento.

    2. Confermare le terapie sperimentali efficaci identificate e le firme dei biomarcatori associati in una fase di espansione (Fase 2) allo scopo di supportare la registrazione di un nuovo farmaco.
    E.2.2Secondary objectives of the trial
    • To evaluate Progression Free Survival (PFS), duration of response, and tumour response by each biomarker/therapeutic combination.
    • To evaluate OS by each biomarker/therapeutic combination.
    • To determine short- and long-term safety signals and quality of life (QOL) measures of an experimental Arm in GBM patients versus standard of care.

    Exploratory Objectives:
    • To generate general prognostic and predictive biomarker hypotheses.
    • To build and validate a longitudinal endpoint model of OS comprised of early assessments (eg, performance status, disease progression) that are associated with OS.
    1. Valutare la sopravvivenza libera da progressione (PFS), la durata della risposta e la risposta del tumore in base a ciascun biomarcatore/combinazione terapeutica.
    2. Valutare l’OS in base a ciascun biomarcatore/combinazione terapeutica.
    3. Determinare i segnali di sicurezza a breve e lungo termine e le misure della qualità della vita (QOL) di un braccio sperimentale nei pazienti con GBM rispetto allo standard di cura.

    Obiettivi esplorativi:
    1. Generare ipotesi prognostiche e predittive generali sui biomarcatori.
    2. Creare e convalidare un modello di endpoint longitudinale di OS composto da valutazioni precoci (ad es., stato di validità, progressione della malattia) che sono associate all’OS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria - Newly Diagnosed:
    • Age = 18 years.
    • Histologically confirmed Grade IV GBM/gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy.
    • - An MRI scan performed within 21 days prior to randomization preferably.
    • Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
    • Karnofsky performance status = 60% performed within a 14-day window prior to randomization.
    • Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

    Main Inclusion Criteria - Recurrent:
    • Age = 18 years.
    • Histologically confirmed GBM/gliosarcoma (WHO criteria; non-IDH R132H mutant) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT).
    • Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
    • Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
    • Baseline MRI performed within 14 days prior to randomization.
    • Karnofsky performance status = 70% performed within a 14-day window prior to randomization.
    • Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.
    • Età =18 anni.
    • GBM/gliosarcoma di grado IV istologicamente confermato (criteri OMS; IDH wild-type mediante immunoistochimica [IHC] o sequenziamento per IDH) stabilito dopo resezione chirurgica o biopsia.
    • Una RM con le sequenze di diagnostica per immagini eseguita preferibilmente nei 21 giorni precedenti la randomizzazione.
    • Uso di desametasone da 4 mg o meno al giorno nei 5 giorni precedenti la randomizzazione.
    • Indice di Karnofsky =60% eseguito entro una finestra temporale di 14 giorni prima della randomizzazione.
    • Disponibilità di tessuto tumorale rappresentativo del glioblastoma dall’intervento chirurgico definitivo o dalla biopsia.

    Tumori ricorrenti:
    • Età =18 anni.
    • GBM/gliosarcoma di grado IV istologicamente confermato (criteri OMS; IDH wild-type) alla prima o alla seconda recidiva dopo terapia iniziale standard, di controllo o sperimentale che includa almeno la RT.
    • Evidenza di malattia ricorrente (RD) dimostrata dalla progressione della malattia mediante criteri RANO leggermente modificati
    • Uso di desametasone da 4 mg o meno al giorno nei 5 giorni precedenti la randomizzazione.
    • Indice di Karnofsky =70% eseguito entro una finestra temporale di 14 giorni prima della randomizzazione.
    • Disponibilità di tessuto tumorale rappresentativo del GBM dall’intervento chirurgico definitivo iniziale e/o intervento chirurgico ricorrente, se eseguito.
    E.4Principal exclusion criteria
    Main Exclusion Criteria - Newly Diagnosed:
    • Any prior treatment for glioma including: prior prolifeprospan 20 with carmustine wafer; prior intracerebral agent; prior radiation treatment for GBM or lower-grade glioma; prior chemotherapy or immunotherapy for GBM or lower-grade glioma.
    • Receiving additional, concurrent, active therapy for GBM outside of the trial
    • Extensive leptomeningeal disease.
    • QTc > 450 msec if male and QTc > 470 msec if female.
    • History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
    • Laboratory results that meet exclusionary parameters.

    Main Exclusion Criteria - Newly Diagnosed:
    • Any prior treatment for glioma including: prior prolifeprospan 20 with carmustine wafer; prior intracerebral agent; prior radiation treatment for GBM or lower-grade glioma; prior chemotherapy or immunotherapy for GBM or lower-grade glioma.
    • Receiving additional, concurrent, active therapy for GBM outside of the trial
    • Extensive leptomeningeal disease.
    • QTc > 450 msec if male and QTc > 470 msec if female.
    • History of another malignancy in the previous 3 years, with a diseasefree interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
    • Laboratory results that meet exclusionary parameters.

    Main Exclusion Criteria - Recurrent Exclusion Criteria:
    • Early disease progression prior to 3 months (12 weeks) from the completion of RT.
    • More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of Temozolomide (TMZ) with an experimental agent is considered one line of chemotherapy.).
    • Any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other VEG)- or VEGF receptormediated targeted agent.
    • Any prior treatment with prolifeprospan 20 with carmustine wafer.
    • Any prior treatment with an intracerebral agent.
    • Receiving additional, concurrent, active therapy for GBM outside of the trial.
    Tumori di nuova diagnosi:
    • Precedente trattamento per glioma, tra cui:
    a. Precedente prolifeprospan 20 con carmustina wafer.
    b. Precedente agente intracerebrale, intratumorale o LCS.
    c. Precedente trattamento con radiazioni per GBM o glioma di basso grado.
    d. Precedente chemioterapia o immunoterapia per GBM o glioma di basso grado.
    • Somministrazione di una terapia aggiuntiva, concomitante, attiva per GBM al di fuori della sperimentazione.
    • Presenza di malattia leptomeningea estesa.
    • QTc >450 msec se di sesso maschile e QTc >470 msec se di sesso femminile.
    • Anamnesi di altra neoplasia maligna nei 3 anni precedenti, con un intervallo libero da malattia <3 anni. I pazienti con anamnesi pregressa di tumore in situ o tumore cutaneo basocellulare o squamocellulare sono idonei.
    • Risultati di laboratorio che soddisfano i parametri di esclusione.

    Criteri di esclusione per tumori ricorrenti:
    1. Progressione precoce della malattia prima dei 3 mesi (12 settimane) dal completamento della RT.
    2. Più di 2 linee precedenti per la somministrazione della chemioterapia. NOTA: nel contesto adiuvante di prima linea, la combinazione di TMZ con un agente sperimentale è considerata 1 linea di chemioterapia.
    3. Qualsiasi trattamento precedente con lomustina, agenti che fanno parte di uno qualsiasi dei bracci sperimentali e bevacizumab o altro fattore di crescita vascolare endoteliale (VEGF) o agente mirato mediato dal recettore VEGF.
    4. Qualsiasi precedente trattamento con prolifeprospan 20 con carmustina wafer.
    5. Qualsiasi trattamento precedente con un agente intracerebrale.
    6. Somministrazione di una terapia aggiuntiva, concomitante, attiva per GBM al di fuori della sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival: defined from the time of randomization to death from any cause.
    Sopravvivenza complessiva: definita come il tempo trascorso dalla randomizzazione alla data del decesso per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall Survival: defined from the time of randomization to death from any cause.
    Sopravvivenza complessiva: definita come il tempo trascorso dalla randomizzazione alla data del decesso per qualsiasi causa.
    E.5.2Secondary end point(s)
    • Progression-Free Survival: defined as the time from randomization to clinically determined progression or death from any cause.
    •Tumor Response:complete response, partial response, progressive disease, stable disease.
    • Duration of Response:(Complete Response + Partial Response) defined as time from date of response to date of clinically determined disease progression or death from any cause.
    • Sopravvivenza libera da progressione: definita come il tempo dalla randomizzazione alla progressione clinicamente determinata o al decesso per qualsiasi causa.
    • Risposta del tumore: classificata in base a risposta completa, risposta parziale, malattia progressiva, malattia stabile.
    • Durata della risposta (risposta completa + risposta parziale): definita come il tempo dalla data della risposta alla data di progressione della malattia clinicamente determinata o al decesso per qualsiasi causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Progression-Free Survival: defined as the time from randomization to clinically determined progression or death from any cause.
    • Tumor Response:complete response, partial response, progressive disease, stable disease.
    • Duration of Response:(Complete Response + Partial Response) defined as time from date of response to date of clinically determined disease progression or death from any cause.
    • Sopravvivenza libera da progressione: definita come il tempo dalla randomizzazione alla progressione clinicamente determinata o al decesso per qualsiasi causa.
    • Risposta del tumore: classificata in base a risposta completa, risposta parziale, malattia progressiva, malattia stabile.
    • Durata della risposta (risposta completa + risposta parziale): definita come il tempo dalla data della risposta alla data di progressione della malattia clinicamente determinata o al decesso per qualsiasi causa.
    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 No
    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.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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio con piattaforma di randomizzazione adattiva alla risposta
    Response Adaptive Randomization Platform Trial
    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
    Temozolomide, Lomustine
    Temozolomide, Lomustine
    E.8.2.4Number of treatment arms in the trial3
    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 EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    United States
    Austria
    France
    Switzerland
    Germany
    Italy
    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
    Last patient, last visit.
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    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 months1
    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: 277
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 355
    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)
    All patients will be followed for safety and OS every 3 months (± 1 month) from study treatment discontinuation or completion until death, withdrawal of consent, or lost to follow up, whichever comes first.
    Tutti i pazienti saranno seguiti per sicurezza e OS ogni 3 mesi (± 1 mese) dall'interruzione o dal completamento del trattamento in studio fino alla morte, al ritiro del consenso o alla perdita al follow-up, a seconda di quale evento si verifichi per primo.
    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 Decision2021-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Mon Apr 29 16:57:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA