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    Summary
    EudraCT Number:2019-003849-15
    Sponsor's Protocol Code Number:CT-P13_3.7
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-07
    Trial 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-003849-15
    A.3Full title of the trial
    A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as
    maintenance therapy in patients with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberCT-P13_3.7
    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 SponsorCelltrion, Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportCelltrion, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion, Inc.
    B.5.2Functional name of contact pointSung Hyun Kim
    B.5.3 Address:
    B.5.3.1Street Address23 Academy-ro
    B.5.3.2Town/ cityYeonsu-gu, Incheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number82328505778
    B.5.5Fax number82328371203
    B.5.6E-mailsunghyun.kim@celltrion.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 Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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.3.2Product code Remsima (CT-P13)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 Inflectra
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 superiority of CT-P13 SC over Placebo SC based on clinical remission at Week 54
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and overall safety including immunogenicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient is male or female aged 18 to 75 years, inclusive.
    -Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points at Screening.
    -Patient with UC, confirmed by endoscopic or radiographic and histological criteria. Histopathology report supporting the diagnosis must be available in the source documents prior to the first administration of the study drug (Day 0).
    -Patient who has been treated for active UC but has not responded despite conventional therapy including corticosteroids alone or in combination with 6-mercaptopurine (6-MP) or azathioprine or who is intolerant to or has medical contraindications to such therapies.
    -Patient who is receiving stable doses of the following UC treatments or currently not receiving UC
    treatment during specified time frame:
    *Azathioprine (AZA), or 6-MP, or methotrexate for at least 8 weeks prior to the first administration of the
    study drug (Day 0)
    *Oral corticosteroids at the equivalent dose of 20 mg/day or less of prednisone for at least 2 weeks
    prior to the first administration of the study drug (Day 0)
    *Oral budesonide at the dose of 9 mg/day or less at least for 2 weeks prior to the first administration
    of the study drug (Day 0)
    *Oral 5-ASA for at least 4 weeks prior to the first administration of the study drug (Day 0)
    *Antibiotics (e.g., ciprofloxacin, metronidazole) for at least 4 weeks prior to the first administration
    of the study drug (Day 0). Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    *Serum creatinine < 1.5×upper limit of normal (ULN) or an estimated creatinine clearance level
    > 50 mL/min (by Cockcroft-Gault formula).
    *Serum alanine aminotransferase < 2.5×ULN
    *Serum aspartate aminotransferase < 2.5×ULN
    *Serum total bilirubin < 2×ULN
    -Patient who has the following clinical hematology results at Screening:
    *Hemoglobin ≥ 8.5 g/dL (SI [Système International d'Unités] units: ≥ 85 g/L or 5.28 mmol/L)
    *White blood cell count ≥ 3.5×10 3 cells/µL (SI units: ≥ 3.5×10 9 cells/L)
    *Neutrophil count ≥ 1.5×10 3 cells/µL (SI units: ≥ 1.5×10 9 cells/L)
    *Platelet count ≥ 100×10 3 cells/µL (SI units: ≥ 100×10 9 cells/L)
    -Patient (or legal guardian, if applicable) who is informed of the full nature and purpose of the study,
    including possible risks and side effects, has the ability to cooperate with the investigator and is given
    ample time and opportunity to read or understand verbal and/or written instructions, and has signed and dated the written informed consent form with date prior to participation in the study.
    -For both male and female patients, the patient and his or her partner of childbearing potential who agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
    *Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    *Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal
    patches, or contraceptive rings)
    *Intrauterine device
    Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any of medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    -Patient who has previously received 2 or more biologic agents, 2 or more JAK inhibitors or 2 or more both biologic agents and JAK inhibitors
    -Patient who has Apreviously received either TNFα inhibitor or biologic agent within 5 half-lives prior to the 1st administration of the IP (Day 0)
    -Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors
    -Patient who has previously received infliximab
    -Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or has a hypersensitivity to immunoglobulin products
    -Patient who has received or has a plan to receive:parenteral corticosteroids for the treatment of UC within 2 wks prior to the 1st administration of IP, rectally administered medications containing corticosteroids or 5-aminosalicylates(5-ASA) for the treatment of UC within 2 wks prior to the 1st administration of the IP, JAK inhibitors including within 4 wks prior to the 1st administration of IP, alkylating agents within 12 mths prior to the 1st administration of IP, cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 8 wks prior to the 1st administration of IP, live or live-attenuated vaccine within 4 wks prior to the 1st administration of IP, abdominal surgery within 6 mths prior to the 1st administration of IP, nonautologous stem cell therapy within 12 mths prior to the 1st administration of IP, apheresis for the treatment of UC within 3 wks prior to the 1st administration of IP, total parenteral nutrition within a month prior to the 1st administration of IP, exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 wks prior to the 1st administration of IP
    -Pt who has a current or history infections: hepatitis B or hepatitis C (active or carrier state) or infection with HIV), acute infection requiring oral antibiotics within 2 wks or parenteral injection of antibiotics within 4 wks prior to the 1st administration of IP, other serious infection within 6 mths prior to the 1st administration of IP, other chronic or recurrent infection within 6 wks prior to the 1st
    administration of IP, Recurrent herpes zoster or other chronic or recurrent infections within 6 wks prior to the 1st administration og IP, past or current granulomatous infections or opportunistic infections or invasive fungal infection, evidence of infection with cytomegalovirus within 6 months prior to the 1st administration of IP, evidence of infection with Clostridium difficile toxin within 3 mths prior to the 1st administration
    of IP, positive stool examinations for enteric pathogens, pathogenic ova or parasites
    -Pt who has a medical condition including 1 or more of the following:
    *Ulcerative colitis limited to only the rectum or to less than 15 cm of the colon
    *Evidence of toxic megacolon
    *Diagnosed with Crohn’s Disease or indeterminate colitis
    *Extensive colonic resection prior to the first administration of IP
    *Evidence of fixed symptomatic stenosis or obstruction of the large intestine
    *Evidence of colonic mucosal dysplasia or adenomatous polyps. 
    *Currently require or are anticipated to require surgical intervention for UC during the study
    *Stoma (e.g., ileostomy or colostomy) within 6 months prior to the first administration of the study drug(Day 0)
    *Body mass index ≥ 5 kg/m 2
    *Uncontrolled diabetes mellitus, even after insulin treatment
    *Uncontrolled hypertension (as defined by systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg)
    *A known malignancy within 5 yrs prior to the first administration of the study drug (Day 0), except completely excised and cured squamous carcinoma in situ of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma
    *History of lymphoma, lymphoproliferative disease, or bone marrow hyperplasia
    *NYHA class III or IV heart failure, severe uncontrolled cardiac disease or myocardial infarction within 6 mths prior to the first administration of the IP
    *History of organ transplantation
    *Significant respiratory disease
    *Demyelinating disorders, including multiple sclerosis nd Guillain Barré syndrome
    *Any conditions significantly affecting the nervous system
    -Pt who has had treatment with any other investigational device or medical product within 4 wks prior to the 1stadministration of IP or 5 half-lives, whichever is longer.
    - Patients who has a current or history of drug or alcohol abuse within 12mnts prior to the 1st administration of IP.
    -Female who is currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 mhs of the last dose of IP
    -Tuberculosis Exclusion Criteria - for these Exclusion Criteria please refer to the Protocol, due to the space restrictions in EudraCT form
    -For the full list of Exclusion Criteria, please refer to the protocol due please refer to the protocol due to the space restrictions in EudraCT form
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission at Week 54, defined as the following modified Mayo score:
    (1) Stool frequency subscore of 0 or 1 point, and
    (2) Rectal bleeding subscore of 0 point, and
    (3) Endoscopic subscore of 0 or 1 point
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 54
    E.5.2Secondary end point(s)
    Key Secondary endpoints:
    - Clinical response at Week 54, defined as a decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point
    - Mucosal healing at Week 54, defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute Robarts Histopathology Index (RHI) score of 3 points or less with an accompanying laminal propria neutrophils and neutrophils in epithelium subscore of 0 point
    - Corticosteroid-free remission at Week 54, defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54,among the patients who used oral corticosteroids at baseline

    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endpoints evaluations will be conducted at Week 54.
    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) No
    E.8.2.2Placebo Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA104
    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
    Belarus
    Bulgaria
    Croatia
    Czech Republic
    France
    Germany
    Israel
    Italy
    Latvia
    Mexico
    Moldova, Republic of
    Peru
    Poland
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 585
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 474
    F.4.2.2In the whole clinical trial 615
    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)
    Patients will transit to local standard of care treatment if required in the opinion of the investigator.
    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 Decision2020-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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