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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   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).
     
    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:2004-000469-36
    Sponsor's Protocol Code Number:46101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-000469-36
    A.3Full title of the trial
    A multicenter, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe vasomotor symptoms associated with the menopause
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number46101
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNV Organon
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameOrg 50081 or (S)+ mirtazapine
    D.3.2Product code Org 50081
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNesmirtazapine
    D.3.9.1CAS number 680993-85-5
    D.3.9.2Current sponsor codeOrg 50081
    D.3.9.3Other descriptive name(14bS)-1,2,3,4,10,14b-hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2] benzazepineZ-2-butenedioate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typea medicinal product with an active substance of chemical origin
    D.IMP: 2
    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 Information not present in EudraCT
    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 nameOrg 50081 or (S)+ mirtazapine
    D.3.2Product code Org 50081
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNesmirtazapine
    D.3.9.1CAS number 680993-85-5
    D.3.9.2Current sponsor codeOrg 50081
    D.3.9.3Other descriptive name(14bS)-1,2,3,4,10,14b-hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2] benzazepineZ-2-butenedioate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typea medicinal product with an active substance of chemical origin
    D.IMP: 3
    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 Information not present in EudraCT
    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 nameOrg 50081 or (S)+ mirtazapine
    D.3.2Product code Org 50081
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNesmirtazapine
    D.3.9.1CAS number 680993-85-5
    D.3.9.2Current sponsor codeOrg 50081
    D.3.9.3Other descriptive name(14bS)-1,2,3,4,10,14b-hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2] benzazepineZ-2-butenedioate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.0
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typea medicinal product with an active substance of chemical origin
    D.IMP: 4
    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 Information not present in EudraCT
    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 nameOrg 50081 or (S)+ mirtazapine
    D.3.2Product code Org 50081
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNesmirtazapine
    D.3.9.1CAS number 680993-85-5
    D.3.9.2Current sponsor codeOrg 50081
    D.3.9.3Other descriptive name(14bS)-1,2,3,4,10,14b-hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2] benzazepineZ-2-butenedioate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 typea medicinal product with an active substance of chemical origin
    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 placeboCapsule, hard
    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
    moderate to severe vasomotor symptoms associated with the menopause
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10020411
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superior efficacy in at least one of the four doses of Org 50081 as compared to placebo on the four following co-primary endpoints:
    1) the mean change from baseline in average daily frequency of moderate to severe vasomotor symptoms at Week 4;
    2) the mean change from baseline in average daily frequency of moderate to severe vasomotor symptoms at Week 12;
    3) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 4;
    4) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 12.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of four different doses of Org 50081 compared to placebo on:
    • the mean change from baseline in average daily frequency, severity and composite score of vasomotor symptoms for each of the 12 weeks of treatment (both including and excluding mild vasomotor symptoms);
    • the percentage of responders and the percentage of remitters during each of the 12 weeks of treatment;
    • health status assessment as measured by the Women’s Health Questionnaire
    during 12 weeks of treatment;
    • safety as measured by routine laboratory parameters, vital signs and (serious) adverse events during 12 weeks of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. postmenopausal women, defined as:
    • 12 months of spontaneous amenorrhea; OR
    • 6 months of spontaneous amenorrhea with serum FSH levels>40 mIU/mL; OR
    • 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
    In case the menopausal status of a subject is unclear because of a hysterectomy,
    the serum FSH level must be >40 mIU/mL. If the date of the last menstruation is
    not clear because of perimenopausal hormone use, then the subject must have a
    serum FSH level >40 mIU/mL after completion of a washout period (see exclusion
    criteria below).
    2. age ≥ 40 and ≤ 65 years;
    3. body mass index (BMI) ≥ 18 and ≤ 32 kg/m2;
    4. minimum of 7 moderate to severe hot flushes per day or 50 per week, as
    quantified from daily diary recordings during at least 7 days preceding
    randomization to trial medication;
    5. able to handle the electronic diary device after training and having at least 80%
    compliance on complete daily diary entries during the period prior to randomization;
    6. give voluntary written informed consent after the scope and nature of the
    investigation have been explained, before screening evaluations.
    E.4Principal exclusion criteria
    7. history or presence of any malignancy, except non-melanoma skin cancers;
    8. any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory,
    hematological, neurological, cardiovascular or cerebro-vascular disease that
    would put the subject at safety risk or mask measure of efficacy;
    9. history of seizures or epilepsy;
    10. history or presence of clinically significant depression or other psychiatric
    disorder which, in the opinion of the investigator, might compromise or confound
    the subject’s participation in the trial;
    11. abnormal, clinically relevant vaginal bleeding;
    12. any clinically relevant (opinion of investigator) abnormal finding during physical,
    gynecological and breast examination at screening;
    13. abnormal, clinically relevant results of mammography. Mammography must have
    been performed within the last 9 months prior to screening, otherwise it must be
    done before inclusion into the trial. For non-US sites, if local laws or guidelines
    do not allow or advise such frequent mammograms, the documented local laws
    or guidelines should be followed;
    14. abnormal cervical smear test results (corresponding to Pap III and higher,
    including LSIL, HSIL, CIN 1 and higher). A cervical smear must have been performed within the last 9 months prior to screening, otherwise it must be done
    before inclusion into the trial;
    15. hematological or biochemical values at screening outside the reference ranges
    considered clinically relevant in the opinion of the investigator;
    16. high blood pressure (sitting systolic BP > 170 mmHg and/or diastolic BP > 100
    mmHg);
    17. use of any drug product containing estrogens, progestins, androgens or tibolone
    prior to screening (and up to and including randomization) within:
    • 1 week for prior vaginal hormonal products (rings, creams, gels)
    • 4 weeks for prior transdermal products
    • 8 weeks for prior oral products
    • 8 weeks for intrauterine therapy
    • 6 months for prior implant, pellet or injectable drug product;
    18. any of the following treatments within the last 4 weeks prior to screening (and up to and including randomization):
    • tricyclic antidepressants, SNRIs, SSRIs, MAO-inhibitors, mirtazapine
    • antianxiety drugs, antipsychotics
    • coumarin-derivatives
    • α-adrenergic agents (e.g. clonidine, methyldopa)
    • β-blockers (e.g., propranolol)
    • dopamine agonists/antagonists (e.g., veralipride, bromocriptine, domperidone)
    • opiates, barbiturates
    • raloxifene
    • homeopathic menopausal preparations or other preparations intended to treat
    climacteric or CNS symptoms (e.g. Black Cohosh, St. John’s Wort, isoflavone
    supplements)
    • hepatic microsomal enzyme-inducing drugs or drugs known to affect or
    interfere with the pharmacokinetics of mirtazapine;
    19. any condition or disease that could affect or interfere with the pharmacokinetics
    of mirtazapine;
    20. subjects sensitive to trial medication or its components;
    21. use of any investigational drug and/or participation in another clinical trial within
    the last 8 weeks prior to screening;
    22. history of alcohol and/or drug abuse within the last two years prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    1) the mean change from baseline in average daily frequency of moderate to severe vasomotor symptoms at Week 4;
    2) the mean change from baseline in average daily frequency of moderate to severe vasomotor symptoms at Week 12;
    3) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 4;
    4) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 12.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state117
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 684
    F.4.2.2In the whole clinical trial 900
    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 Decision2004-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-01-17
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA