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   44334   clinical trials with a EudraCT protocol, of which   7366   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:2008-001464-36
    Sponsor's Protocol Code Number:GS-US-174-0121
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-001464-36
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B who are Resistant to Lamivudine
    Estudio aleatorizado, doble ciego y doble enmascarado de fase 3b para evaluar la eficacia antiviral, seguridad y tolerabilidad de la monoterapia con tenofovir disoproxil fumarato (DF) frente a la terapia en combinación fija de emtricitabina más tenofovir DF en pacientes con hepatitis B crónica resistentes a lamivudina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigation of the effectiveness and safety of Tenofovir Disoproxil Fumarate (TDF) given on its own versus Emtricitabine and TDF taken together in patients with long lasting Hepatitis B for whom lamivudine therapy has not been successful due to the virus becoming resistant to its action
    Investigación de la eficacia y seguridad de Tenofovir Disoproxil Fumarato (TDF) solo versus emtricitabina y TDF tomados juntos en pacientes con hepatitis B de larga duración en los cuales la terapia con lamivudina no ha tenido éxito y a que el virus ha llegado a ser resistente a su acción.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    No aplicable
    A.4.1Sponsor's protocol code numberGS-US-174-0121
    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 SponsorGilead Sciences 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 supportGilead Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ city4611 University Drive, Foster City
    B.5.3.3Post codeCA94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 1 650 522 5592
    B.5.5Fax number+ 1 650 522 1975
    B.5.6E-mailJohn.Flaherty@gilead.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 Viread
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated 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 INNtenofovir disoproxil fumarate
    D.3.9.1CAS number 52232-67-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeanti-retroviral agent
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated 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 INNemtricitabine
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeFTC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenofovir disoproxil fumarate
    D.3.9.1CAS number 52232-67-4
    D.3.9.2Current sponsor codeTDF
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeanti-retroviral agent
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis B
    Hepatitis B crónica
    E.1.1.1Medical condition in easily understood language
    Active long term infection with hepatitis B virus
    Infección activa a largo plazo con virus de la hepatitis B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? To compare the antiviral efficacy against hepatitis B virus (HBV) of once-daily tenofovir DF versus once-daily emtricitabine plus tenofovir DF combination treatment in subjects with lamivudine resistance
    ? Comparar la eficacia antiviral contra el VHB de tenofovir DF una vez al día frente al tratamiento en
    combinación de emtricitabina más tenofovir DF una vez al día en pacientes resistentes a lamivudina.
    E.2.2Secondary objectives of the trial
    ? To evaluate the safety and tolerability of tenofovir DF versus emtricitabine plus tenofovir DF combination treatment in subjects with lamivudine resistance
    ? To evaluate the biochemical and serological responses to tenofovir DF versus emtricitabine plus tenofovir DF in subjects with lamivudine resistance
    ? To compare changes in the resistance profile of each treatment arm over the duration of the study
    ? To evaluate the steady-state pharmacokinetics of tenofovir in subjects with lamivudine resistance
    ? Evaluar la seguridad y tolerabilidad de tenofovir DF comparado con emtricitabina más tenofovir DF en combinación en sujetos con resistencia a lamivudina
    Evaluar la respuesta bioquímica y serológica a tenofovir DF comparado con emtricitabina más tenofovir DF en combinación en sujetos con resistencia a lamivudina
    Comparar los cambios en el perfil de resistencias de cada brazo de tratamiento sobre la duración del estudio
    Evaluar la farmacocinética del estado estacionario de tenofovir en sujetos con resistencia a la lamivudina
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) substudy objective:

    ? To evaluate the pharmacokinetics of tenofovir in subjects with calculated creatinine clearance (CLcr) 50?80 mL/min
    Objetivo del subestudio de farmacocinética:
    Evaluar la farmacocinética de tenofovir en sujetos con aclaramiento de creatinina calculado (ClCr) 50-80 ML/min
    E.3Principal inclusion criteria
    ? Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
    ? Males and females, 18 through 75 years of age, inclusive. In Greece, only postmenopausal and/or surgically sterile women may participate.
    ? HBV DNA ? 10^3 copies/mL
    ? Currently receiving lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization.
    ? Prior or current adefovir dipivoxil treatment of ? 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) is allowed
    ? Willing and able to provide written informed consent
    ? Negative serum ?-HCG (for females of childbearing potential only),
    ? Calculated creatinine clearance ? 50 mL/min
    ? Hemoglobin ? 10 g/dL
    ? Neutrophils ? 1,000 /mm3
    ? No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil.
    ? Infección crónica por el VHB, definida como HBsAg positivo en suero durante al menos 6 meses.
    ? De 18 a 75 años de edad, ambos inclusive.
    ? >103 UI/mL de ADN del VHB.
    ? Estar recibiendo lamivudina con confirmación de mutaciones de la transcriptasa inversa del VHB
    conocidas porque confieren resistencia a lamivudina (rtM204I/V con o sin rtL180M) según la
    evaluación del laboratorio central antes de la asignación aleatoria.
    ? Se permite el tratamiento previo o actual con dipivoxilo de adefovir durante < ó = 48 semanas en el
    momento de la selección (incluso la combinación de dipivoxilo de adefovir + lamivudina en el
    momento de la entrada en el estudio).
    ? Estar dispuesto y ser capaz de proporcionar el consentimiento informado por escrito.
    ? Prueba de GCH sérica negativa (únicamente en caso de mujeres en edad fértil).
    ? Aclaramiento de creatinina confirmado > ó = 50 ml/min
    ? Hemoglobina > ó =10 g/dl.
    ? Neutrófilos > ó =1.000/mm3
    ? Sin tratamiento oral anti-VHB previo con nucleótidos y/o nucleósidos aprobados ni con otros fármacos en investigación para la infección por VHB, a parte de lamivudina o dipivoxilo de adefovir
    E.4Principal exclusion criteria
    ? Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
    ? Males of reproductive potential who are not willing to use an ?effective? method of contraception during the study. This should be, at minimum, a condom.
    ? ALT ? 10 × ULN
    ? Decompensated liver disease defined as direct (conjugated) bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mm3, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).
    ? Received interferon (pegylated or not) therapy within 6 months of the screening visit
    ? ? -fetoprotein > 50 ng/mL
    ? Evidence of HCC
    ? Co infection with HCV (by serology), HIV, or HDV
    ? Significant renal, cardiovascular, pulmonary, or neurological disease
    ? Received solid organ or bone marrow transplantation
    ? Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
    ? Has proximal tubulopathy
    ? Known hypersensitivity to the study drugs, the metabolites or formulation excipients
    ? Mujeres embarazas, que estén en periodo de lactancia o que crean o deseen quedarse embarazadas
    durante el transcurso del estudio.
    ? Varones y mujeres con capacidad reproductiva que no deseen utilizar un método anticonceptivo
    «eficaz» durante el estudio. Los varones deben utilizar preservativos y las mujeres un método
    anticonceptivo de barrera en combinación con cualquier otro método.
    ? ALT > ó = 10 veces el LSN.
    ? Enfermedad hepática descompensada definida como bilirrubina directa (conjugada) > 1,5 veces el
    LSN, tiempo de protrombina (TP) > 1,5 veces el LSN, recuento de plaquetas < 75.000/mm3,
    albúmina sérica < 3,0 g/dl o antecedentes previos de descompensación hepática clínica (p. ej.,
    ascitis, ictericia, encefalopatía, hemorragia por varices).
    ? Tratamiento con interferón (pegilado o no) recibido en los 6 meses anteriores a la visita de selección.
    ? alfa fetoproteína > 50 ng/ml.
    ? Evidencia de CHC.
    ? Coinfección con VHC (según la serología), VIH o VHD.
    ? Enfermedad renal, cardiovascular, pulmonar o neurológica significativa.
    ? Receptor de un trasplante de órgano sólido o de médula ósea.
    ? Estar recibiendo tratamiento con inmunomoduladores (p. ej., corticoides, etc.), fármacos en
    investigación, fármacos nefrotóxicos o susceptible de modificar la excreción renal.
    ? Presenta tubulopatía proximal.
    ? Hipersensibilidad conocida a los fármacos del estudio, los metabolitos o los excipientes de la
    formulación.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is HBV DNA < 400 copies/mL at Week 96.
    El objetivo de valoración de la eficacia es DNA HBV < 400 copias/mL en la semana 96
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 96
    Semana 96
    E.5.2Secondary end point(s)
    Secondary endpoints include: HBV DNA < 169 copies/mL, HBV DNA level, ALT normal, virologic breakthrough, HBeAg/HBsAg loss and seroconversion, and development of drug resistant
    mutations.
    Los objetivos de valoración secundarios incluyen: HBV DNA< 169 copias/mL, nivel de HBV DNA, ALT normal, respuesta virológica, pérdida de HBeAg/HBsAg y seroconversión y desarrollo de las mutaciones de resistencia la fármaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 96 & 240
    Semanas 96 y 240
    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 Yes
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Canada
    New Zealand
    Serbia
    Turkey
    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
    The end of study is defined when each subject reaches Week 240.
    El final del estudio se define cuando cada sujeto alcanza la semana 240
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 239
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 250
    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)
    After the completion of the study participation, long term care for the participants will remain the responsibility of their primary treating physicians.
    Después de completar la participación en el estudio, el cuidado a largo plazo de los participantes continuará siendo responsabilidad de su médico de atención primaria
    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 Decision2008-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-09
    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-Sat May 03 11:09:15 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA