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    EudraCT Number:2010-022384-35
    Sponsor's Protocol Code Number:CCX114644
    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:2012-03-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022384-35
    A.3Full title of the trial
    An Open-Label Extension Study to Assess the Safety of GSK1605786A in
    Subjects with Crohn's Disease
    Studio di estensione in aperto per valutare la sicurezza di GSK1605786A in soggetti affetti da morbo di Crohn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 25 month study of a potential new medicine (GSK1605786A) for the
    treatment of Crohn's disease
    Studio della durata di 25 mesi su di un potenziale farmaco (GSK1605786A)per il trattamento del Morbo di Crohn.
    A.3.2Name or abbreviated title of the trial where available
    Open label extension study
    Studio di estensione in aperto
    A.4.1Sponsor's protocol code numberCCX114644
    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.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 990 44 66
    B.5.5Fax number+44 0208 990 12 34
    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 nameGSK1605786A
    D.3.2Product code GSK1605786A
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeGSK1605786A
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Subjects with Crohn's Disease
    Soggetti affetti dal Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease Inflammatory bowel disease
    Soggetti con infiammazione intestinale da Morbo di Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of long-term treatment with GSK1605786A in subjects with Crohn's disease.
    Valutare la sicurezza e la tollerabilità del trattamento con GSK1605786A in soggetti con morbo di Crohn.
    E.2.2Secondary objectives of the trial
    To assess the effectiveness of long-term treatment with GSK1605786A • To assess changes in health-related quality of life • To assess changes in healthcare-related resource utilisation • To assess changes in work productivity and activity impairment • To assess changes in unemployment and disability rates • To assess changes in C-reactive protein (CRP) as a biomarker of inflammation • To potentially evaluate the correlation of genetic markers with the safety and effectiveness of GSK1605786A.
    • Valutare l'efficacia del trattamento a lungo termine con GSK1605786A • Valutare le variazioni della qualità della vita correlata alla salute • Valutare le variazioni dell'utilizzo delle risorse collegate alla salute • Valutare le variazioni della produttività al lavoro e della riduzione dell'attività • Valutare le variazioni del tasso di disoccupazione e del tasso di invalidità • Valutare le variazioni della proteina C-reattiva (PCR) come biomarcatore dell'infiammazione • Valutare potenzialmente la correlazione dei marcatori genetici con la sicurezza e l'efficacia di GSK1605786A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previous participation in a GSK-sponsored study with GSK1605786A as follows: a. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI => 100 point decrease) or clinical remission (CDAI < 150) at Week 12 or completion of other GSKsponsored induction studies, with the exception of Study CCX114643, as designated by the sponsor b. completion of maintenance study CCX114157 at Week 52 c. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change 2. Written informed consent prior to any CCX114644-specific study procedures 3. Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following: Contraceptive Methods with a Failure Rate of < 1% • Abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle • Oral contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of etonogestrel or levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label • Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel's: review of subject's medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history. • Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository) • Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
    1. Precedente partecipazione a un studio con GSK1605786A sponsorizzato da GSK, come segue: a. Completamento dello studio d'induzione controllato verso placebo, CCX114151, senza ottenere risposta clinica (diminuzione di punti di CDAI 100) o remissione clinica (CDAI &lt;150) alla Settimana 12 o completamento di altri studi d'induzione sponsorizzati da GSK, ad eccezione dello studio CCX114643, come indicato dallo sponsor b. Completamento dello studio di mantenimento CCX114157 alla Settimana 52 c. Ritiro dallo studio di mantenimento CCX114157 dovuto a peggioramento del morbo di Crohn che necessiti di un cambio del trattamento. 2. Consenso informato prima di qualsiasi procedura specifica allo studio CCX114644 3. Le donne in età fertile devono essere sessualmente inattive, o devono impegnarsi ad usare metodi anticoncezionali con un tasso di fallimento &lt; 1% all'anno se utilizzati in modo costante e corretto e, se applicabile, in conformità con l'etichetta del prodotto, per la durata di questo studio, come definito da quanto segue: Metodi contraccettivi con un tasso di fallimento di &lt;1% • Astinenza dal rapporto sessuale pene-vagina, qualora questo faccia parte dello stile di vita preferito e regolare della donna • Contraccettivo orale, sia combinato che progestinico da solo • Progestinico iniettabile • Impianti di etonogestrel o levonorgestrel • Anello vaginale estrogenico • Cerotto anticoncezionale percutaneo • Dispositivo intrauterino (IUD) o sistema intrauterino (IUS) che soddisfino il tasso di fallimento &lt;1%, come indicato sull'etichetta del prodotto • Sterilizzazione del partner di sesso maschile prima che la partner di sesso femminile venga ammessa allo studio, e che tale partner di sesso maschile sia il partner esclusivo della paziente. Le informazioni sulla sterilità maschile possono essere ottenute dal personale del centro che si occupa di: esaminare la cartella clinica del soggetto; sottoporre il soggetto a visita medica e/o analisi del liquido seminale; o di intervistare il soggetto in relazione alla sua anamnesi. • Preservativo maschile combinato con spermicida vaginale (schiuma, gel, pellicola, crema, o supposta) • Preservativo maschile combinato con diaframma femminile, con o senza spermicida vaginale (schiuma, gel, pellicola, crema, o supposta) Questi metodi contraccettivi consentiti sono efficaci solo se utilizzati correttamente e costantemente, in conformità con l'etichetta del prodotto. Lo Sperimentatore è responsabile di assicurarsi che i soggetti capiscano come usare correttamente i metodi di contraccezione. Questo elenco non si applica alle donne in età fertile con partner dello stesso sesso, quando questo è il loro stile di vita preferito e consueto. I soggetti di sesso femminile non devono essere arruolati se sono in stato di gravidanza o allattamento, o se prevedono di iniziare una gravidanza durante il periodo di partecipazione allo studio. Un test di gravidanza sulle urine sarà ripetuto nel corso dello studio.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breastfeeding, or is planning to become pregnant 2. Subjects with known or suspected coeliac disease or a positive screening test for antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive test result. 3. Fixed symptomatic stenoses of small bowel or colon 4. Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period 5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks 6. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies) 7. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject. 8. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the Investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.
    Non sono ammessi scostamenti rispetto ai criteri di esclusione in quanto questi potrebbero potenzialmente compromettere l'integrità scientifica dello studio, l'accettabilità normativa e la sicurezza. Pertanto, l'aderenza ai criteri specificati nel protocollo è essenziale. Non devono essere arruolati nello studio i soggetti che soddisfano uno qualsiasi dei criteri seguenti: Anche se i soggetti sono già stati arruolati in uno studio precedente sponsorizzato da GSK con GSK1605786A, lo Sperimentatore deve garantire le seguenti esclusioni: 1. Se paziente di sesso femminile, è in stato di gravidanza, ha esito positivo da test di gravidanza o sta allattando, o sta pianificando una gravidanza 2. I soggetti affetti da nota o sospetta malattia celiaca o con test di screening positivo ad anticorpi anti-transglutaminasi tessutale (anti-tTG) devono essere esclusi dall'arruolamento a qualsiasi studio d'induzione. I soggetti nei quali venga successivamente sospettata diagnosi di malattia celiaca devono essere sottoposti a test per gli anticorpi anti-tTG, e esclusi o ritirati dallo studio se ricevono risultato positivo dal test 3. Stenosi sintomatiche fisse dell'intestino tenue o del colon 4. Fistole enterocutanee, addominali o pelviche che richiedano interventi chirurgici durante il periodo dello studio 5. Sepsi o infezioni in corso che richiedano terapia antibiotica endovenosa &gt;2 settimane 6. Uso di farmaci vietati alla baseline e durante lo studio (Sezione 5.4.2 Farmaci vietati e terapie non farmacologiche) 7. Il soggetto mostra evidenza di disfunzione epatica o epatite virale; ha livelli sierici di ALT (SGPT) e/o AST (SGOT) valori 2 volte il limite superiore della norma, valore totale di bilirubina &gt;1,5 volte il limite superiore della norma (la bilirubina isolata &gt;1,5 x ULN è accettabile se la bilirubina è frazionata, e bilirubina diretta &lt; 35%), o fosfatasi alcalina &gt;1,5 volte il limite superiore della norma; ha anamnesi attuale o cronica di malattia epatica compresa steatoepatite non alcolica (NASH); o soffre di insufficienza epatica o anomalie biliari ad eccezione della sindrome di Gilbert o calcoli biliari asintomatici. 8. Soggetti che hanno problemi dimostrati di sicurezza e tollerabilità durante la partecipazione ad uno studio precedente con GSK1605786A, che, a parere del ricercatore, erano possibilmente correlati al trattamento dello studio e pongono un rischio inaccettabile per il soggetto. Al fine di garantire la continuità del trattamento dello studio, i soggetti cominceranno il trattamento alla baseline prima di ricevere i risultati dei test di funzionalità epatica o degli anticorpi anti-tTG (se applicabile). Se i risultati di questi test indicheranno che il soggetto soddisfa i criteri di esclusione, il soggetto dovrà essere escluso dallo studio, registrato come paziente risultato non idoneo e escluso a causa di incapacità di soddisfare i criteri di continuazione dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events/Serious adverse events
    Incidenza di eventi avversi/eventi avversi gravi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112. 12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112. CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.
    Valutazione della sicurezza alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112. Valutazione ECG alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112. Valutazione CDAI alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112.
    E.5.2Secondary end point(s)
    • Change from baseline in vital signs: heart rate and blood pressure. • Change from baseline in haematology and clinical chemistry parameters. • Change from baseline in liver function test parameters. • Change from baseline in 12 lead ECG abnormalities.
    • Variazione rispetto alla baseline dei segni vitali: frequenza cardiaca e pressione sanguigna • Variazione rispetto alla baseline dei parametri di ematologia e chimica clinica • Variazione rispetto alla baseline dei parametri dei test di funzionalità epatica • Variazione rispetto alla baseline delle anomalie dell'ECG a 12 derivazioni.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112. 12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112. CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.
    Valutazione della sicurezza alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112. Valutazione ECG alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112. Valutazione CDAI alla settimana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 e dopo 4 settimane di follow up, settimana 112.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety 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 Yes
    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. 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA158
    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
    Hong Kong
    Korea, Republic of
    New Zealand
    Russian Federation
    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
    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 months46
    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 months46
    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: 766
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 800
    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)
    The investigator is responsible for the post-study care of the patient's
    medical condition.
    The study will be conducted for 108 weeks. The risk-to-benefit ratio
    will be re-assessed when the results of induction study CCX114151 are
    available and at periodic intervals thereafter. If appropriate, the
    duration of the open-label study may be amended.
    Lo Sperimentatore è responsabiledeltrattamento del paziente una volta terminatolo studio.
    Lo studio durerà 108 settimaneIl rapporto rischio/beneficio verràrivalutatoquando i risultati dello studio CCX114151 saranno disponibili e quindi ad intervalli periodici: Se appropriato, la durata dello studio in aperto potrà essere modificata.
    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 Decision2012-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-14
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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