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    Clinical Trial Results:
    An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

    Summary
    EudraCT number
    2015-003536-12
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jan 2017
    First version publication date
    04 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025B1301E1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01328886
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess the long-term safety and tolerability of omalizumab as add-on therapy in Japanese pediatric subjects with inadequately controlled allergic asthma despite current recommended treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Mar 2011
    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
    Japan: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    0
    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)
    21
    Adolescents (12-17 years)
    17
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 15 centers in Japan.

    Pre-assignment
    Screening details
    This study was the extension study of the core study CIGE025B1301 (EudraCT Number: 2015-003534-27).

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    The study was open label study, hence no blinding was performed.

    Arms
    Arm title
    Omalizumab
    Arm description
    Omalizumab 75 to 375 mg was administered subcutaneously (sc) every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum immunoglobulin E (IgE) level at screening visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    IGE025B
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered with Omalizumab 75 to 375 mg subcutaneously every 2 or 4 weeks.

    Number of subjects in period 1
    Omalizumab
    Started
    38
    Completed
    35
    Not completed
    3
         Lack of efficacy
    1
         Consent withdrawn by subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    -

    Reporting group values
    Overall period Total
    Number of subjects
    38 38
    Age categorical
    Units: Subjects
        Children (2-11 years)
    21 21
        Adolescents (12-17 years)
    17 17
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.5 ± 2.52 -
    Gender categorical
    Units: Subjects
        Female
    15 15
        Male
    23 23

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    Omalizumab 75 to 375 mg was administered subcutaneously (sc) every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum immunoglobulin E (IgE) level at screening visit.

    Primary: Number of subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), AE leading to discontinuation and who died

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    End point title
    Number of subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), AE leading to discontinuation and who died [1]
    End point description
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population, defined subjects with at least one dose of study medication during the study..
    End point type
    Primary
    End point timeframe
    From day 1 to 30 days post last study treatment
    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: Only descriptive summary statistics was planned for this outcome measure.
    End point values
    Omalizumab
    Number of subjects analysed
    38
    Units: Subjects
        AEs
    38
        SAEs
    10
        SAEs other than asthma exacerbation
    4
        Asthma exacerbation
    7
        Death
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    Omalizumab 75 to 375 mg was administered sc every 2 or 4 weeks depending on the dose. Omalizumab dose was individualized for each subject, based on their body weight and total serum IgE level at screening visit.

    Serious adverse events
    Omalizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 38 (26.32%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Omalizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 38 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Food allergy
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Application site erythema
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Application site swelling
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Discomfort
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Injection site eczema
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Injection site erythema
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Injection site swelling
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Malaise
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    9 / 38 (23.68%)
         occurrences all number
    14
    Swelling
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Dysphoria
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Psychosomatic disease
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Contusion
         subjects affected / exposed
    8 / 38 (21.05%)
         occurrences all number
    10
    Epicondylitis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Epiphyseal injury
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Foot fracture
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Heat illness
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Injury
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    6 / 38 (15.79%)
         occurrences all number
    7
    Scratch
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Wound
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Investigations
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Urine output decreased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    6 / 38 (15.79%)
         occurrences all number
    10
    Cough
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    5
    Upper respiratory tract inflammation
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 38 (28.95%)
         occurrences all number
    16
    Migraine
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Orthostatic intolerance
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Conjunctivitis allergic
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    6
    Eczema eyelids
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Eye swelling
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Myopia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Visual acuity reduced
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Auricular perichondritis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    6
    Abdominal pain upper
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Cheilitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    4
    Dental caries
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Gastritis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Enterocolitis
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Periodontal disease
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Radicular cyst
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    8
    Toothache
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    6 / 38 (15.79%)
         occurrences all number
    6
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Asteatosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Dermatitis atopic
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    10 / 38 (26.32%)
         occurrences all number
    11
    Eczema nummular
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    5 / 38 (13.16%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Arthropathy
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    4
    Growing pains
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Infrapatellar fat pad inflammation
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Upper extremity mass
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Infections and infestations
    Body tinea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Acute tonsillitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    5
    Bronchitis viral
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Chronic sinusitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    6 / 38 (15.79%)
         occurrences all number
    8
    Gingivitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Herpangina
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Impetigo
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    15 / 38 (39.47%)
         occurrences all number
    17
    Injection site infection
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Kaposi's varicelliform eruption
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Mumps
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    20 / 38 (52.63%)
         occurrences all number
    52
    Oral herpes
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Otitis externa
         subjects affected / exposed
    4 / 38 (10.53%)
         occurrences all number
    4
    Otitis media
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Otitis media acute
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Parotitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    7 / 38 (18.42%)
         occurrences all number
    10
    Pneumonia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Sinobronchitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    3
    Streptococcal infection
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 38 (36.84%)
         occurrences all number
    34

    More information

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    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
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