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    Summary
    EudraCT Number:2010-024473-39
    Sponsor's Protocol Code Number:CINC424A2401
    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:2011-12-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-024473-39
    A.3Full title of the trial
    An open-label, multicenter, expanded access study of INC424 for patients with primary myelofibrosis (PMF) or
    post polycythemia myelofibrosis (PPV MF) or postessential thrombocythemia myelofibrosis (PET-MF)
    Studio in aperto, multicentrico, di accesso allargato a INC424 in pazienti con mielofibrosi primaria (PMF) o mielofibrosi post-policitemia vera (PPV MF) o mielofibrosi posttrombocitemia essenziale (PET-MF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy study of INC424 in patients with myelofibrosis
    Sicurezza e efficacia di INC424 in pazienti con mielofibrosi
    A.4.1Sponsor's protocol code numberCINC424A2401
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/572 e EU/3/09/620
    D.3 Description of the IMP
    D.3.1Product nameruxolitinib
    D.3.2Product code INC424
    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 INNruxolitinib
    D.3.9.2Current sponsor codeINC424
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF) or Post essential thrombocythemia myelofibrosis (PET-MF)
    Mielofibrosi primaria (PMF) o mielofibrosi post-policitemia vera (PPV MF) o mielofibrosi posttrombocitemia essenziale (PET-MF)
    E.1.1.1Medical condition in easily understood language
    Myelofibrosis
    Mielofibrosi
    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 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To collect additional safety of INC424 in patients with PMF, PPV MF, or PET MF, who have either received prior treatment with commercially available agents or never received treatment
    Raccogliere dati aggiuntivi di sicurezza d’impiego di INC424 in pazienti con PMF, PPV MF o PET-MF che siano stati sottoposti a trattamento precedente con farmaci disponibili in commercio o che non abbiano mai ricevuto alcun trattamento
    E.2.2Secondary objectives of the trial
    -To document the best overall response rate to INC424 in patients with PMF, PPV MF , or PET MF as evaluated by the investigator; -To collect quality of life (QoL) endpoints; - To document medical resource utilization
    -Documentare il tasso di miglior risposta complessiva di INC424 in pazienti con PMF, PPV MF o PET-MF, in base alla valutazione dello sperimentatore; -Raccogliere valutazioni relative alla qualità della vita (QoL) in pazienti con PMF, PPV MF o PET-MF trattati con INC424; -Documentare l’utilizzo delle risorse mediche (MRU) in pazienti con PMF, PPV MF o PET-MF trattati con INC424.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must give written informed consent according to local guidelines prior to any screening procedures; 2. Patients must not be eligible for another ongoing INC424 clinical trial; 3. Male or female patients aged ≥ 18 years of age; 4. Patients must be diagnosed with PMF, PPV-MF or PET-MF, according to the 2008 World Health Organization criteria, irrespective of JAK2 mutation status; 5. PMF patients requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen. The prognostic factors, defined by the International Working Group are described in Section 1.1; 6. Patients with Intermediate-1 and splenomegaly, must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion; 7. Patients with a peripheral blood blast count of < 10%; 8. Patients with adequate liver function defined as direct bilirubin ≤ 2.0 x ULN, and ALT ≤ 2.5 x ULN; 9. Patients with adequate renal function defined as serum creatinine ≤ 2 x ULN; 10. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 11. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of study drug; 12. Patients must have recovered or stabilized sufficiently from adverse drug reactions associated with prior treatments before beginning treatment with INC424.
    1. I pazienti devono fornire il proprio consenso informato scritto in base alle linee-guida locali, prima di qualsiasi procedura di screening; 2. I pazienti non devono essere eleggibili per un altro studio clinico in corso con INC424; 3. Soggetti di entrambi i sessi ed età uguale o superiore a 18 anni; 4. Diagnosi di mielofibrosi primaria (PMF), mielofibrosi post-policitemia vera (PPV-MF) o mielofibrosi post-trombocitemia essenziale (PET-MF), indipendentemente dallo status mutazionale JAK2, in base ai criteri del World Health Organization 2008;5. I pazienti con mielofibrosi primaria che richiedono trattamento devono essere classificati come pazienti a livello di rischio elevato (3 fattori prognostici) OPPURE a livello di rischio intermedio 2 (2 fattori prognostici) OPPURE a livello di rischio intermedio 1 (1 fattore prognostico) con splenomegalia. I fattori prognostici, definiti dall’IWG (International Working Group) sono descritti nella Sezione 1.1 del protocollo; 6. I pazienti con livello di rischio intermedio 1 e splenomegalia devono presentare una milza palpabile sporgente 5 cm o più dal margine costale al punto di maggior protrusione; 7. Pazienti con conta dei blasti nel sangue periferico &lt; 10%; 8. Pazienti con funzionalità epatica adeguata, definita da bilirubina &lt; 2,0 x ULN e ALT &lt; 2,5 x ULN; 9. Pazienti con funzionalità renale adeguata, definita da creatinina sierica &lt; 2,0 x ULN; 10. Pazienti con Eastern Cooperative Oncology Group (ECOG) performance status di 0, 1 o 2; 11. Le donne potenzialmente fertili devono avere un test di gravidanza sul siero negativo entro i 14 giorni precedenti la somministrazione del trattamento in studio; 12. I pazienti devono aver manifestato risoluzione o sufficiente stabilizzazione degli eventi avversi associati ai trattamenti precedenti, prima di iniziare il trattamento con INC424.
    E.4Principal exclusion criteria
    1.Patients eligible for hematopoietic stem cell transplantation; 2. Patients with a history of malignancy in the past 3 years, except for treated early stage squamous or basal cell carcinoma in situ 3. patients undergoing treatment with hematopoietic growth factor receptor agonists, granulocyte colony stimulant factor at nay time within 2 weeks prior to screening or 4 weeks prior to baseline; 4. Patients currently participating in COMFORT-I and COMFORT -II trials; 5.Patients receiving any medications listed in the ''prohibited medications'' listing; 6. Impairment of GI function or GI disease that may alter the absorption of INC424; 7. Patients with cardiac disease which my jeopardize the safety of the patient; 8. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal fibrillation or recent myocardial infarction or acute coronary syndrome; 9. Patients with clinically significant infections (for further details see protocol); 10. Patients with known active hepatitis a, B, C or who are HIV –positive; 11. Patients with coagulation parameters; 12.Pregnant or nursing women.
    1. Pazienti eleggibili al trapianto di cellule staminali emopoietiche (che sono candidati e che hanno un donatore adeguato disponibile); 2. Pazienti che hanno manifestato una neoplasia nei 3 anni precedenti, a eccezione di carcinoma a cellule squamose o carcinoma a cellule basali in situ in stadio precoce trattati; 3. Pazienti sottoposti a trattamento con agonisti del recettore del fattore di crescita ematopoietico, come ad esempio, eritropoietina (EPO), fattore di stimolazione delle colonie di granulociti (GCSF), romiplostim, eltrombopag, in qualsiasi momento nelle 2 settimane precedenti lo screening o nelle 4 settimane precedenti il basale; 4. Pazienti che stanno partecipando agli studi COMFORT-I e COMFORT-II; 5. Pazienti in trattamento concomitante con qualsiasi farmaco elencato nella lista dei “farmaci non permessi”; 6. Pazienti con compromissione della funzionalità gastrointestinale o patologia gastrointestinale che possa significativamente alterare l’assorbimento orale di INC424 (ad es. ulcera, nausea non controllata, vomito, diarrea, sindrome da malassorbimento o resezione dell’intestino tenue); 7. Pazienti con cardiopatie che possano, secondo l’opinione dello sperimentatore, compromettere la sicurezza del paziente o l’aderenza al protocollo; 8. Pazienti con angina non controllata o angina instabile, fibrillazione rapida o parossistica attuale o infarto miocardico o sindrome coronarica acuta recenti (6 mesi circa); 9. Pazienti con infezioni batteriche, micotiche, parassitarie o virali clinicamente rilevanti che necessitano di trattamento. I soggetti con infezioni batteriche acute che necessitano di terapia antibiotica devono ritardare lo screening/arruolamento fino a quando il ciclo di terapia antibiotica non sia stato completato; 10. Pazienti con epatite A, B o C in fase attiva nota o con positività HIV; 11. Pazienti con riserva midollare inadeguata come dimostrato da: a. Conta assoluta dei neutrofili (ANC) &lt; 1000/μL, b. Conta piastrinica &lt; 100.000/μL senza l’aiuto di fattori di crescita, fattori trombopoietici o trasfusioni piastriniche; 12. Pazienti con anamnesi positiva per conta piastrinica &lt; 50.000/μL o ANC &lt; 500/μL salvo durante il trattamento per malattia mieloproliferativa o il trattamento con terapia citotossica per qualsiasi altro motivo.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: - Clinical and laboratory parameters will be collected to evaluate study drug safety and toxicity; - Safety and tolerability will be collected by monitoring the frequency, duration and severity of all grade adverse events (AEs) by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v. 3 0), performing physical exams (PE), and evaluating changes in vital signs (VS), ECOG performance status (PS), electrocardiograms (ECGs) and serum chemistry and hematology results; - Grade 3 and 4 AEs, Serious Adverse Events (SAEs); - Physicians will be required to report all SAEs and pregnancies to Novartis or designee. Data collection forms and safety reporting requirements will be provided to physicians for this purpose. Physicians will be made aware of emerging safety issues via the same procedures utilized by Novartis to notify investigators in other trials; -Frequency of dose interruptions and discontinuations due to AEs.
    Sicurezza d’impiego: - Per valutare la sicurezza d’impiego e la tossicità del trattamento in studio saranno raccolti i parametri clinici e di laboratorio; - I dati di sicurezza d’impiego e di tollerabilità saranno raccolti monitorando la frequenza, la durata e la gravità degli eventi avversi di tutti i gradi (AE) stabiliti in base alla classificazione del National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v. 3.0), eseguendo un esame obiettivo e valutando le modificazioni dei segni vitali, dell’ECOG performance status, degli elettrocardiogrammi e dei risultati delle valutazioni biochimiche ed ematologiche; - Eventi avversi di Grado 3 e 4, eventi avversi seri (SAEs); - Gli sperimentatori dovranno riportare a Novartis o al personale da questa designato tutti gli eventi avversi seri (SAEs) e tutte le gravidanze. A questo scopo saranno forniti agli sperimentatori i moduli per la raccolta dei dati e le procedure per le segnalazioni di sicurezza. Gli sperimentatori saranno informati circa i problemi di sicurezza d’impiego emergenti mediante gli stessi canali utilizzati da Novartis per le segnalazioni agli sperimentatori che sono state utilizzate in altri studi clinici; - Incidenza delle interruzioni della somministrazione della dose e sospensioni dovute agli eventi avversi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly for the first 3 months, then every 3 months and at study discontinuation
    Mensilmente per i primi 3 mesi, poi ogni 3 mesi e all'interruzione dello studio
    E.5.2Secondary end point(s)
    Quality of Life: - Change in ECOG PS from Baseline to each visit where measured; - Change in FACT-Lym from baseline to each visit where measured; - Change in Functional Assessment of Chronic Illness Therapy (FACIT): Fatigue from baseline to each visit where measured
    Qualità della vita: - Modificazioni rispetto al basale dell’ECOG performance status a ogni visita durante la quale viene misurato; - Modificazioni rispetto al basale del FACT-Lym a ogni visita durante la quale viene misurato; - Modificazioni del FACIT (Functional Assessment of Chronic Illness Therapy): Valutazione rispetto al basale dell’affaticamento a ogni visita durante la quale viene misurata
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly for the first 3 months, then every 3 months and at study discontinuation
    Mensilmente per i primi 3 mesi, poi ogni 3 mesi e all'interruzione dello studio
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned61
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA263
    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
    Argentina
    Brazil
    Canada
    Colombia
    Korea, Republic of
    Lebanon
    Mexico
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Venezuela, Bolivarian Republic of
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months31
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 0
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 570
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 782
    F.4.2.2In the whole clinical trial 950
    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)
    INC424will be administered continously until either disease progression, unacceptable toxicity, death, discontinuation, until the drug becomes commercially available or until24 months after LPLV whichever occurs first.If INC424 not available after the marketing or 24months after LPFV Novartis will implement a transition plan to ensure access to the drug INC424 without delaying treatment.
    Il trattamento continuerà fino a: progressione della malattia,comparsa di tossicità inaccettabile,decesso, interruzione dello studio,disponibilità in commercio del farmaco in ciascun Paese partecipante o fino al Mese24 a partire dallaLPFV,a seconda di quale evento si verifica per primo.SeINC424 non fosse disponibile dopo la commercializzazione o 24mesi dopo la LPFV Novartis attuerà un piano di transizione per garantire l’accesso al farmaco INC424 senza ritardare il trattamento
    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 Decision2011-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-26
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