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    Summary
    EudraCT Number:2016-002855-48
    Sponsor's Protocol Code Number:BAY1002670/15789
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-08
    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 number2016-002855-48
    A.3Full title of the trial
    A randomized, parallel-group, double-blind, double-dummy, activecontrolled,
    multicenter study to assess the efficacy and safety of vilaprisan
    in subjects with uterine fibroids
    Studio multicentrico, randomizzato, per gruppi paralleli, in doppio cieco secondo la modalità double-dummy, controllato con farmaco attivo volto alla valutazione dell'efficacia e della sicurezza di vilaprisan in pazienti con fibromi uterini
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids
    Valutazione della sicurezza e dell'efficacia di vilaprisan in pazienti con fibromi uterini
    A.3.2Name or abbreviated title of the trial where available
    ASTEROID 5
    ASTEORID 5
    A.4.1Sponsor's protocol code numberBAY1002670/15789
    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 SponsorBAYER HEALTHCARE AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address"EU CTR"
    B.5.3.2Town/ cityBerlino
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number004930300139003
    B.5.5Fax number004930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY1002670 coated tablet 2 mg 245
    D.3.2Product code BAY1002670
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVilaprisan
    D.3.9.1CAS number 1262108-14-4
    D.3.9.2Current sponsor codeBAY1002670
    D.3.9.3Other descriptive nameBAY1002670
    D.3.9.4EV Substance CodeSUB31208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 ESMYA - 5 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC/PE/PVDC) 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderGEDEON RICHTER PLC
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameesmya 5 mg tablets
    D.3.2Product code na
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNULIPRISTAL ACETATO
    D.3.9.1CAS number 126784-99-4
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameULIPRISTAL ACETATO
    D.3.9.4EV Substance CodeSUB30470
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    leiomyoma
    fibrosi uterina
    E.1.1.1Medical condition in easily understood language
    Uterine fibroids, heavy menstrual bleeding
    fibrosi uterina, cliclo mestruale abbondante
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016628
    E.1.2Term Fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046784
    E.1.2Term Uterine fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10022794
    E.1.2Term Intramural leiomyoma of uterus
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of vilaprisan
    in subjects with uterine fibroids compared to ulipristal.
    Obiettivo principale di questo studio è di valutare l'efficacia di vilaprisan in pazienti con fibromi uterini rispetto a ulipristal.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy and
    safety of different treatment regimens of vilaprisan in subjects with
    uterine fibroids
    L'obiettivo secondaro diq uesto studio è di valutare l' efficacia e la sicurezza di vari regimi terapeutici di vilaprisan in soggetti con fibromi uterini
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women, 18 years or older at the time of Visit 1
    2. Diagnosis of uterine fibroid(s) documented by ultrasound at screening
    with at least 1 fibroid with largest diameter more than 30 mm and less
    than 120 mm
    3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual
    pictogram (MP) in a bleeding episode period during the screening period
    4.Use of an acceptable non-hormonal method of contraception
    5. An endometrial biopsy performed during the screening period, without
    significant histological disorder such as endometrial hyperplasia
    (including simple hyperplasia) or other significant endometrial
    pathology.
    1) Donne di età pari o superiore a 18 anni
    2)1 fibroma uterino documentato per via ecografica allo screening con diametro massimo  30 mm e < 120 mm
    3)mestruazioni abbondanti (HMB)  80,0 ml documentate mediante pittogramma mestruale (MP) in una mestruazione durante il periodo di screening
    4. uso di un metodo contraccettivo non ormonale consentito
    5.Biopsia dell’endometrio effettuata durante lo screening senza alcuna evidenza di patologie istologiche come ad esempio iperplasia endometriale
    E.4Principal exclusion criteria
    1. Pregnancy or lactation (less than 3 months since delivery, abortion, or
    lactation before start of treatment)2. Hypersensitivity to any ingredient of the study drugs
    3. Hemoglobin values £6 g/dL or any condition requiring immediate
    blood transfusion (subjects with hemoglobin values £10.9 g/dL will be
    recommended to use iron supplementation).
    4. Any diseases, conditions, or medications that can compromise the
    function of the body systems and could result in altered absorption,
    excessive accumulation, impaired metabolism, or altered excretion of
    the study drug including
    5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
    6. Undiagnosed abnormal genital bleeding
    7. Any diseases or conditions that might interfere with the conduct of the
    study or the interpretation of the results.
    1. Gravidanza o allattamento (meno di 3 mesi dal parto, aborto, o allattamento prima dell’inizio del trattamento)
    2. Ipersensibilità ad uno degli eccipienti del farmaco in studio
    3. Valori di emoglobina di 6 g/dL o qualsiasi altra condizione che richieda una trasfusione di sangue immediata (ai soggetti con un valore di emoglobina pari a 10.9 g/dL si raccomanda l’integrazione con ferro)
    4. Qualsiasi condizione, patologia o farmaco che possa compromettere la funzionalità corporea portando a un alterato assorbimento, un eccessivo accumulo, un ridotto metabolismo o alterata eliminazione del farmaco in studio come:
    5. Abuso di alcool, droghe o farmaci (ad esempio lassativi)
    6. Sanguinamento genitale anormale non diagnosticato
    7. Qualsiasi condizione o malattia che possa interferire con la conduzione dello studio o con l’interpretazione dei risultati.
    E.5 End points
    E.5.1Primary end point(s)
    Amenorrhea (yes/no), Defined as menstrual blood loss (MBL) < 2 mL
    based on the menstrual pictogram (MP) during last 28 days of the
    treatment period.
    Amenorrea (sì/no), definita come flusso mestruale (MBL) < 2 ml sulla base del pittogramma mestruale (MP) negli ultimi 28 giorni del periodo di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 months and 9 months
    3 mesi e 9 mesi
    E.5.2Secondary end point(s)
    1) Amenorrhea (yes/no); Defined as menstrual blood loss (MBL) < 2 mL
    based on the menstrual pictogram (MP) during last 28 days of the
    treatment period.
    2) Absence of bleeding (yes/no); defined as no bleeding (spotting
    allowed) during the last 28 days of the treatment; based on the UF-DBD
    3) Number of bleeding days;
    4) Time to onset of controlled bleeding; Onset of controlled bleeding is
    defined by the first day, for which the menstrual blood loss (assessed by
    Menstrual pictogram) is less than 80.0 mL.
    5) Heavy Menstrual Bleeding responder rate; Percentage of subjects
    with blood loss < 80.0 mL and 50% reduction compared to baseline
    (assessed by Menstrual Pictogram)
    6) Percent change in volume of largest fibroid compared to baseline
    measured by MRI
    7) Endometrial histology' Assess benign endometrium, presence or
    absence of hyperplasia or malignancy
    8) Endometrial thickness by ultrasound
    1. Amenorrea (si/no): definita come perdita di sangue mestruale < 2 ml basata sull’analisi del pittogramma durante gli ultimi 28 giorni del periodo di trattamento
    2. Assenza di sanguinamenti (si/no): definita come assenza di sanguinamento (spotting è permesso) durante gli ultimi 28 giorni del periodo di trattamento; basata sul questionario UF-DBD
    3. Numero di giorni di sanguinamento
    4. Tempo intercorso dalla comparsa di sanguinamento incontrollato; comparsa di sanguinamento controllato è definita come il primo giorno per il quale la perdita di sangue mestruale (valutata tramite pittogramma) è inferiore a 80 ml
    5. Velocità di risposta del sanguinamento mestruale intenso; percentuale di soggetti con una perdita di sangue mestruale <80 ml e il 50% di riduzione rispetto al basale (valutato tramite pittogramma)
    6. Percentuale di cambiamento in volume del fibroma più grande rispetto alla misurazione effettuata al basale tramite MRI
    7. Istologia dell’endometrio: valutazione dell’endometrio, presenza o assenza di iperplasia o segni di malignità
    8. Spessore dell’endometrio misurato con ultrasuoni
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Amenorrhea At 6 months, at 12 months, at 15 months, at 18 months,
    at 21 months and at 24 months
    2) Absence of bleeding up to 24 months
    3) Number of bleeding days from day 1 of the first treatment period until
    the day before the next treatment period after the last treatment period
    would start again normalized to 28 days
    4) Time to onset of controlled bleeding at quarterly up to 24 months
    5) Heavy Menstrual Bleeding responder rate; by treatment period up to
    24 months
    6) Percent change in volume of largest fibroid compared to baseline at
    baseline, at 12 months and at 24 months
    7) Endometrial histology at baseline, at 12 months and at 24 months
    8) Endometrial thickness once per 3-months-treatment period
    1. Amenorrea a 6 mesi, 12 mesi, 15 mesi, a 18 mesi a 21 mesi e a 24 mesi
    2. Assenza di sanguinamento fino a 24 mesi
    3. numero di giorni di sanguinamento- dal giorno 1 del primo periodo di trattamento fino al giorno che precede il successivo periodo di trattamento dopo che l'ultimo periodo di trattamento sarebbe ricominciato normalizzato a 28 gg
    4. Tempo all’insorgenza di sanguinamento controllato ogni tre mesi e fino a 24 mesi
    5. Velocità di risposta del sanguinamento mestruale intenso; dal periodo di trattamento fino a 24 mesi
    6. Percentuale di cambiamento in volume del fibroma più grande rispetto alla misurazione effettuata al basale, al basale, a 12 mesi e a 24 mesi
    7. Istologia dell’endometrio al basale, a 12 mesi e a 24 mesi
    8. Spessore dell’endometrio una volta per ogni periodo di t
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA210
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Taiwan
    Ukraine
    United Kingdom
    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 years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 996
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 722
    F.4.2.2In the whole clinical trial 996
    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 pregnancies occurring during the treatment and follow-up periods
    will be followed for the outcome for both the mother and fetus/child
    (in a case of life birth) until first birthday of the child.
    Tutte le gravidanze che si verificano durante il periodo di trattamento e di follow-up verranno seguite per registrare il risultato sia per la madre, sia per il feto/bambino (nel caso in cui nasca vivo), fino al compimento del primo anno del bambino.
    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 Decision2017-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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.

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