Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A 12-Week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2016-000061-23
    Trial protocol
    		 SK   PL  
    Global end of trial date
    31 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D1001067
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    84 Waterford Drive , Marlborough, United States, 01752
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.com
    Scientific contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the long-term safety of lurasidone (40 and 80 mg/day) in subjects with schizophrenia who have completed participation in Study D1001066.
    Protection of trial subjects
    This study was conducted according to the protocol, International Council for Harmonization (ICH) Good Clinical Practice (GCP) and the ethical principles that have their origin in the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Ukraine: 124
    Country: Number of subjects enrolled
    Russian Federation: 82
    Country: Number of subjects enrolled
    Japan: 71
    Worldwide total number of subjects
    289
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    282
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 subjects must have completed the 6-week double-blind phase of study D1001066 and must have completed all required assessments on the final study visit

    Pre-assignment
    Screening details
    		 Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Anxiety/depression) at each post-baseline visit

    Period 1
    Period 1 title
    Overall Study-Open Label (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 lurasidone
    Arm description
    		 Flexable doeses (40 or 80 mg/day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Latuda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    flexable doese (40 or 80 mg/day)

    Number of subjects in period 1
    		lurasidone
    Started
    289
    Completed
    235
    Not completed
    54
         Consent withdrawn by subject
    28
         Adverse event, non-fatal
    17
         reason not given
    4
         Lack of efficacy
    4
         Protocol deviation
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study-Open Label
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study-Open Label Total
    Number of subjects
    		 289 289
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 282 282
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.1 ± 11.23 -
    Gender categorical
    Units: Subjects
        Female
    		 144 144
        Male
    		 145 145

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Flexable doeses (40 or 80 mg/day)

    Primary: Frequency of Adverse Events (AEs) or treatment related AEs, extrapyramidal AEs, SAEs, and AEs leading to study discontinuation

    		 Close Top of page
    End point title
    		 Frequency of Adverse Events (AEs) or treatment related AEs, extrapyramidal AEs, SAEs, and AEs leading to study discontinuation [1]
    End point description
    End point type
    Primary
    End point timeframe
    Overall study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: this was an open label study - there was no statistical analysis required
    End point values
    		 lurasidone
    Number of subjects analysed
    289 [2]
    Units: events
        Frequency of Adverse Events
    146
        Frequency of treatment-related Adverse Events
    100
        Frequency of extrapyramidal Adverse Events
    28
        Frequency of Serious Adverse Events
    14
        Frequency of AEs leading to study discontinuation
    18
    Notes
    [2] - safety population
    No statistical analyses for this end point

    Primary: Proportion of subjects using concomitant antiparkinsonian drugs

    		 Close Top of page
    End point title
    		 Proportion of subjects using concomitant antiparkinsonian drugs [3]
    End point description
    End point type
    Primary
    End point timeframe
    overall study
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: this was an open label study - there was no statistical analysis required
    End point values
    		 lurasidone
    Number of subjects analysed
    289 [4]
    Units: participants
        Subjects using concomitant antiparkinsonian drugs
    21
    Notes
    [4] - safety population
    No statistical analyses for this end point

    Primary: Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale [5]
    End point description
    Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) total score (excluding the overall severity) at each post-baseline visit
    End point type
    Primary
    End point timeframe
    Up to day 92 (follow-up)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: this was an open label study - there was no statistical analysis required
    End point values
    		 lurasidone
    Number of subjects analysed
    289 [6]
    Units: score
    arithmetic mean (standard deviation)
        Day 1
    0.4 ± 1.15
        Day 8
    0.4 ± 1.18
        Day 15
    0.5 ± 1.28
        Day 29
    0.4 ± 1.08
        Day 57
    0.4 ± 1.17
        Day 85
    0.4 ± 1.13
        Day 92 (follow-up)
    0.3 ± 0.81
    Notes
    [6] - safety population
    No statistical analyses for this end point

    Primary: Frequency of subjects with suicidal behavior and suicidal ideation

    		 Close Top of page
    End point title
    		 Frequency of subjects with suicidal behavior and suicidal ideation [7]
    End point description
    Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point type
    Primary
    End point timeframe
    Overall study
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: this was an open label study - there was no statistical analysis required
    End point values
    		 lurasidone
    Number of subjects analysed
    289 [8]
    Units: events
        Suicidial behavior
    1
        Suicidal ideation
    7
    Notes
    [8] - safety population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-blind baseline in (PANSS) score at each baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-blind baseline in (PANSS) score at each baseline visit
    End point description
    Change from Open-label and Double-blind baseline in Positive and Negative Syndrome Scale (PANSS) score at each baseline visit
    End point type
    Secondary
    End point timeframe
    Open-label (OL) Baseline, Double-blind (DB) Baseline, Week 1, Week 2, Week4, Week 8, Week 12, Week 1 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [9]
    Units: units on a scale
    least squares mean (standard error)
        Double-Blind Baseline
    101.1 ± 11.00
        Open-Label Baseline
    80.5 ± 15.80
        Week 1
    79.0 ± 16.45
        Week 2
    75.9 ± 16.09
        Week 4
    73.9 ± 15.29
        Week 8
    71.5 ± 15.70
        Week 12
    68.9 ± 15.72
        Week 12 (LOCF)
    71.7 ± 18.22
    Notes
    [9] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-blind Baseline in (CGI-S)score at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-blind Baseline in (CGI-S)score at each post-baseline visit
    End point description
    Change from Open-label and Double-blind Baseline in Clinical Global Impression-Severity Scale (CGI-S)score at each post-baseline visit
    End point type
    Secondary
    End point timeframe
    Open-label (OL) Baseline, Double-blind (DB) Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [10]
    Units: units on a scale
    least squares mean (standard error)
        Double blind baseline
    4.9 ± 0.60
        Open-label baseline
    3.9 ± 0.89
        Week 1
    3.8 ± 0.87
        Week 2
    3.7 ± 0.84
        Week 4
    3.5 ± 0.85
        Week 8
    3.4 ± 0.82
        Week 12
    3.3 ± 0.82
        Week 12 (LOCF)
    3.4 ± 0.92
    Notes
    [10] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS subscale scores (Positive scale) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS subscale scores (Positive scale) at each post-baseline visit
    End point description
    Positive scale
    End point type
    Secondary
    End point timeframe
    Double-blind Baseline, Open-label Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [11]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    25.3 ± 3.80
        Open-label baseline
    19.0 ± 5.31
        Week 1
    18.5 ± 5.42
        Week 2
    17.5 ± 5.06
        Week 4
    17.0 ± 4.73
        Week 8
    16.1 ± 4.56
        Week 12
    15.6 ± 4.68
        Week 12 (LOCF)
    16.4 ± 5.50
    Notes
    [11] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS subscale scores (Negative scale) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS subscale scores (Negative scale) at each post-baseline visit
    End point description
    Negative scale
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [12]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    24.2 ± 4.08
        Open-label baseline
    20.7 ± 4.49
        Week 1
    20.4 ± 4.53
        Week 2
    19.7 ± 4.67
        Week 4
    19.3 ± 4.57
        Week 8
    18.8 ± 4.65
        Week 12
    18.3 ± 4.59
        Week 12 (LOCF)
    18.9 ± 4.95
    Notes
    [12] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS subscale scores (General psychopathology scale) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS subscale scores (General psychopathology scale) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [13]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    51.5 ± 6.41
        Open-label baseline
    40.9 ± 8.29
        Week 1
    40.2 ± 8.56
        Week 2
    38.7 ± 8.46
        Week 4
    37.7 ± 8.01
        Week 8
    35.1 ± 8.33
        Week 12
    36.5 ± 9.58
    Notes
    [13] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS subscale scores (Negative symptom scale) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS subscale scores (Negative symptom scale) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [14]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    21.1 ± 3.75
        Open-label baseline
    17.4 ± 4.09
        Week 1
    17.1 ± 4.16
        Week 2
    16.7 ± 4.16
        Week 4
    16.3 ± 4.12
        Week 8
    15.9 ± 4.24
        Week 12
    15.3 ± 4.10
        Week 12 (LOCF)
    15.8 ± 4.42
    Notes
    [14] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Excitement) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Excitement) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [15]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    11.5 ± 2.90
        Open-label baseline
    8.9 ± 3.16
        Week 1
    8.7 ± 3.26
        Week 2
    8.4 ± 3.12
        Week 4
    8.1 ± 2.85
        Week 8
    7.7 ± 2.82
        Week 12
    7.5 ± 2.92
        Week 12 (LOCF)
    7.9 ± 3.29
    Notes
    [15] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Cognitive disorders) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Cognitive disorders) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [16]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    16.3 ± 2.67
        Open-label baseline
    13.8 ± 3.15
        Week 1
    13.7 ± 3.14
        Week 2
    13.2 ± 3.29
        Week 4
    13.0 ± 3.00
        Week 8
    12.6 ± 2.90
        Week 12
    12.2 ± 3.29
        Week 12 (LOCF)
    12.6 ± 3.29
    Notes
    [16] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Positive symptoms) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Positive symptoms) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [17]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    15.7 ± 2.38
        Open-label baseline
    15.7 ± 11.9
        Week 1
    11.5 ± 3.41
        Week 2
    10.9 ± 3.16
        Week 4
    10.5 ± 3.13
        Week 8
    10.0 ± 3.07
        Week 12
    9.6 ± 3.11
        Week 12 (LOCF)
    10.1 ± 3.52
    Notes
    [17] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Anxiety/depression) at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-bline Baseline in PANSS five-factor model scores (Anxiety/depression) at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [18]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    16.1 ± 3.33
        Open-label baseline
    12.0 ± 3.51
        Week 1
    11.8 ± 3.48
        Week 2
    11.3 ± 3.43
        Week 4
    11.1 ± 3.24
        Week 8
    10.8 ± 3.30
        Week 12
    10.3 ± 3.46
        Week 12 (LOCF)
    10.8 ± 3.80
    Notes
    [18] - ITT population
    No statistical analyses for this end point

    Secondary: Change from Open-label and Double-blind Baseline in Calgary Depression Scale for Schizophrenia (CDSS) total scores at each post-baseline visit

    		 Close Top of page
    End point title
    		 Change from Open-label and Double-blind Baseline in Calgary Depression Scale for Schizophrenia (CDSS) total scores at each post-baseline visit
    End point description
    End point type
    Secondary
    End point timeframe
    Double-blind baseline, Open-label baseline, Week 4, Week 12, Week 12 (LOCF)
    End point values
    		 lurasidone
    Number of subjects analysed
    287 [19]
    Units: units on a scale
    least squares mean (standard error)
        Double-blind baseline
    4.1 ± 3.73
        Open-label baseline
    2.4 ± 2.85
        Week 4
    2.2 ± 3.02
        Week 12
    1.8 ± 2.70
        Week 12 (LOCF)
    2.0 ± 2.84
    Notes
    [19] - ITT population
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    During the 12 week treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Flexable doeses (40 or 80 mg/day)

    Serious adverse events
    		 lurasidone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 289 (4.84%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    12 / 289 (4.15%)
         occurrences causally related to treatment / all
    7 / 15
         deaths causally related to treatment / all
    0 / 0
    Impulsive behaviour
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 lurasidone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 289 (12.46%)
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    19 / 289 (6.57%)
         occurrences all number
    20
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    19

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 05:01:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA