List Name (used in database) Display Namet-investigator-role G.1 National coordinating investigator for a multicentre trialt-investigator-role G.1 Principal investigator for a single centre trialt-investigator-role G.2 Other principal investigator for a multicentre trialapplicant-identification The sponsorapplicant-identification The legal representative of the sponsorapplicant-identification A person or organisation authorised by the sponsorapplicant-identification-s The sponsor applicant-identification-s The legal representative of the sponsorapplicant-identification-s A person or organisation authorised by the sponsorapplicant-identification-s Coordinating investigator (for multicentre trial)applicant-identification-s Principal investigator (for single centre trial)concentration-unit log10 FAI50 log10 fluorescent assay infectious dose 50%concentration-unit log10 FAI50/dose log10 fluorescent assay infectious dose 50%/dosconcentration-unit log10 PFU log10 plaque forming unit(s)concentration-unit log10 PFU/dose log10 plaque forming unit(s)/doseconcentration-unit log10 TCID50 log10 tissue culture infective dose 50concentration-unit log10 TCID50/dose log10 tissue culture infective dose 50/doseconcentration-unit log10/ml log10/mlconcentration-unit LU loomis unitconcentration-unit LU/g loomis unit/gramconcentration-unit LU/ml loomis unit/millilitreconcentration-unit lm lumenconcentration-unit lx luxconcentration-unit MBq/Aµg megabecquerel(s)/microgramconcentration-unit MBq/Aµl megabecquerel(s)/microlitreconcentration-unit m meterconcentration-unit mCi/kg millicurie(s)/kilogramconcentration-unit mCi/g millicurie(s)/gramconcentration-unit mCi/mg millicurie(s)/milligramconcentration-unit mCi/Aµg millicurie(s)/microgramconcentration-unit AµCi/l microcurie(s)/litreconcentration-unit AµCi/ml microcurie(s)/millilitreconcentration-unit AµCi/Aµl microcurie(s)/microlitreconcentration-unit AµCi/kg microcurie(s)/kilogramconcentration-unit AµCi/g microcurie(s)/gramconcentration-unit AµCi/mg microcurie(s)/milligramconcentration-unit AµCi/Aµg microcurie(s)/microgramconcentration-unit IU/g international unit(s)/gramconcentration-unit IU/mg international unit(s)/milligramconcentration-unit IU/l international unit(s)/litreconcentration-unit IU/ml international unit(s)/millilitreconcentration-unit mEq/l milliequivalent(s)/litreconcentration-unit mEq/ml milliequivalent(s)/millilitreconcentration-unit mEq/Aµl milliequivalent(s)/microlitreconcentration-unit mEq/kg milliequivalent(s)/kilogramconcentration-unit mEq/g milliequivalent(s)/gramconcentration-unit mEq/mg milliequivalent(s)/milligramconcentration-unit mEq/Aµg milliequivalent(s)/microgramconcentration-unit kg/m2 kilogram(s)/square meterconcentration-unit mmol millimole(s)concentration-unit mmol/l millimole(s)/litreconcentration-unit mmol/ml millimole(s)/millilitreconcentration-unit mmol/kg millimole(s)/kilogram

concentration-unit mmol/g millimole(s)/gramconcentration-unit % (W/W) percent weight/weightconcentration-unit % (W/V) percent weight/volumeconcentration-unit % (V/V) percent volume/volumeconcentration-unit mg/g milligram(s)/gramconcentration-unit PFU plaque forming unitconcentration-unit Aµl/ml microlitre(s)/millilitreconcentration-unit U unit(s)concentration-unit 1X 100 milligrams/millilitreconcentration-unit EID50 50% Embryo Infective Doseconcentration-unit EID50/dose 50% Embryo Infective Dose/doseconcentration-unit AU/ml allergy unit(s)/millilitreconcentration-unit A ampereconcentration-unit AgU antigen unit(s)concentration-unit AgU/ml antigen unit(s)/millilitreconcentration-unit ATU anti-thrombin unit(s)concentration-unit anti-Xa IU anti-Xa activity International Unit(s)concentration-unit anti-Xa IU/ml anti-Xa activity International Unit(s)/millilitreconcentration-unit billion CFU billion colony forming unitsconcentration-unit billion CFU/g billion colony forming units/gramconcentration-unit billion CFU/ml billion colony forming units/millilitreconcentration-unit billion organisms billion organismsconcentration-unit billion organisms/g billion organisms/gramconcentration-unit billion organisms/mg billion organisms/milligramconcentration-unit billion organisms/ml billion organisms/millilitreconcentration-unit cd candelaconcentration-unit CCID50 cell culture infective dose 50concentration-unit CCID50/dose cell culture infective dose 50/doseconcentration-unit A°C celsius temperatureconcentration-unit CFU/g colony forming unit(s)/gramconcentration-unit Otherconcentration-unit W wattconcentration-unit Wb weberconcentration-unit mg/h milligram(s)/hourconcentration-unit SU Standardised Unit(s) (Deprecated)concentration-unit SU/ml Standardised Unit(s)/millilitre (Deprecated)concentration-unit SQU Standardised Quality Unit(s) (Deprecated)concentration-unit SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated)concentration-unit BAU Bioequivalent Allergy Unit(s)concentration-unit BAU/ml Bioequivalent Allergy Unit(s)/millilitreconcentration-unit mg/kg/h milligram(s)/kilogram/hourconcentration-unit Aµkat microkatalconcentration-unit Aµkat microkatal(s)concentration-unit Aµmol micromole(s)concentration-unit Aµmole/l micromole(s)/litreconcentration-unit Aµmole/ml micromole(s)/millilitreconcentration-unit mkat millikatalconcentration-unit ml/cm2 millilitre(s)/square cmconcentration-unit mm millimeter(s)concentration-unit million CFU million colony forming unitsconcentration-unit million CFU/g million colony forming units/gramconcentration-unit million CFU/ml million colony forming units/millilitreconcentration-unit million IU million international unitsconcentration-unit million organisms million organisms

concentration-unit million organisms/g million organisms/gramconcentration-unit million organisms/mg million organisms/milligramconcentration-unit million organisms/ml million organisms/millilitreconcentration-unit Munit million unitsconcentration-unit mOsm/kg milliosmol(s)/kilogramconcentration-unit min minuteconcentration-unit nCi nanocurie(s)concentration-unit ng nanogram(s)concentration-unit nkat nanokatalconcentration-unit nl nanolitre(s)concentration-unit nmol nanomole(s)concentration-unit nmol/ml nanomole(s)/millilitreconcentration-unit N newtonconcentration-unit NIH units/cm2 NIH units of Thrombin inhibited/square centimeterconcentration-unit O ohmconcentration-unit OZ ounceconcentration-unit PPM part per millionconcentration-unit P pascalconcentration-unit pg picogram(s)concentration-unit pkat picokatalconcentration-unit PFU e.1000 mouse LD50 plaque forming unit equiv 1000 mouse Lconcentration-unit PFU/dose plaque forming unit(s)/doseconcentration-unit PFU/ml plaque forming unit(s)/millilitreconcentration-unit pock forming unit pock forming unit(s)concentration-unit LB poundconcentration-unit pressor units/ml pressor units/millilitreconcentration-unit PNU/ml protein nitrogen units/millilitreconcentration-unit QS quantity sufficientconcentration-unit r/min revolution/minuteconcentration-unit s secondconcentration-unit S siemensconcentration-unit Sv sievertconcentration-unit cm2 square centimeterconcentration-unit m2 square meterconcentration-unit T teslaconcentration-unit thousand CFU thousand colony forming unitsconcentration-unit thousand CFU/g thousand colony forming units/gramconcentration-unit thousand CFU/mL thousand colony forming units/millitreconcentration-unit thousand organisms thousand organismsconcentration-unit thousand organisms/g thousand organisms/gramconcentration-unit thousand organisms/ml thousand organisms/millilitreconcentration-unit TCID50/dose tissue culture infective dose 50/doseconcentration-unit titre titreconcentration-unit t tonneconcentration-unit tuberculin unit tuberculin unit(s)concentration-unit tuberculin unit/ml tuberculin unit(s)/millitreconcentration-unit U/g unit(s)/gramconcentration-unit U/ml unit(s)/millilitreconcentration-unit V voltconcentration-unit CFU/ml colony forming unit(s)/millilitreconcentration-unit Co coulombconcentration-unit m3 cubic meterconcentration-unit DAgU D antigen unit(s)concentration-unit DAgU/ml D antigen unit(s)/millilitre

concentration-unit d dayconcentration-unit A° degreeconcentration-unit ELISA unit enzyme-linked immunosorbent assay unitconcentration-unit ELISA unit/dose enzyme-linked immunosorbent assay unit/doseconcentration-unit ELISA unit/ml enzyme-linked immunosorbent assay unit/millitreconcentration-unit F faradconcentration-unit FAI50 fluorescent assay infectious dose 50%concentration-unit FAI50/dose fluorescent assay infectious dose 50%/doseconcentration-unit GBq gigabecquerel(s)concentration-unit GBq/g gigabecquerel/gramconcentration-unit GBq/Kg gigabecquerel/kilogramconcentration-unit GBq/l gigabecquerel/litreconcentration-unit GBq/Aµg gigabecquerel/microgramconcentration-unit GBq/Aµl gigabecquerel/microlitreconcentration-unit GBq/mg gigabecquerel/milligramconcentration-unit GBq/ml gigabecquerel/millilitreconcentration-unit gm/m2 gram(s)/square meterconcentration-unit Gy grayconcentration-unit H henryconcentration-unit Hz hertzconcentration-unit h hourconcentration-unit IOU international opacity unit(s)concentration-unit J jouleconcentration-unit KIU/ml kallikrein inactivator unit/millilitreconcentration-unit kat katalconcentration-unit K kelvinconcentration-unit kIU kilo international unitsconcentration-unit kunit kilo unitsconcentration-unit KBq/Kg kilobecquerel(s)/kilogramconcentration-unit LacU lactose unit(s)concentration-unit LfU lime flocculation unit(s)concentration-unit LfU/ml lime flocculation unit(s)/millilitreconcentration-unit log10 EID50 log 10 50% embryo infective doseconcentration-unit log10 EID50/dose log 10 50% embryo infective dose/doseconcentration-unit log10 CCID50 log10 cell culture infective dose 50concentration-unit log10 CCID50/dose log10 cell culture infective dose 50/doseconcentration-unit log10 ELISA unit log10 enzyme-linked immunosorbent assay unitconcentration-unit log10 ELISA unit/dose log10 enzyme-linked immunosorbent assay uconcentration-unit kg kilogram(s)concentration-unit g gram(s)concentration-unit mg milligram(s)concentration-unit Aµg microgram(s)concentration-unit mg/kg milligram(s)/kilogramconcentration-unit Aµg/kg microgram(s)/kilogramconcentration-unit mg/m2 milligram(s)/square meterconcentration-unit Aµg/m2 microgram(s)/square meterconcentration-unit l litre(s)concentration-unit ml millilitre(s)concentration-unit Aµl microlitre(s)concentration-unit Bq becquerel(s)concentration-unit MBq megabecquerel(s)concentration-unit kBq kilobecquerel(s)concentration-unit Ci curie(s)concentration-unit mCi millicurie(s)

concentration-unit AµCi microcurie(s)concentration-unit mol mole(s)concentration-unit IU international unit(s)concentration-unit IU/kg international unit(s)/kilogramconcentration-unit mEq milliequivalent(s)concentration-unit % percentconcentration-unit Gtt drop(s)concentration-unit DF dosage formconcentration-unit kg/m3 kilogram(s)/cubic meterconcentration-unit g/m3 gram(s)/cubic meterconcentration-unit mg/m3 milligram(s)/cubic meterconcentration-unit Aµg/m3 microgram(s)/cubic meterconcentration-unit kg/l kilogram(s)/litreconcentration-unit g/l gram(s)/litreconcentration-unit mg/l milligram(s)/litreconcentration-unit Aµg/l microgram(s)/litreconcentration-unit g/ml gram(s)/millilitreconcentration-unit mg/ml milligram(s)/millilitreconcentration-unit Aµg/ml microgram(s)/millilitreconcentration-unit Aµg/Aµl microgram(s)/microlitreconcentration-unit mol/kg mole(s)/kilogramconcentration-unit mol/g mole(s)/gramconcentration-unit mol/mg mole(s)/milligramconcentration-unit mol/l mole(s)/litreconcentration-unit mol/ml mole(s)/millilitreconcentration-unit Bq/l becquerel(s)/litreconcentration-unit Bq/ml becquerel(s)/millilitreconcentration-unit Bq/Aµl becquerel(s)/microlitreconcentration-unit Bq/kg becquerel(s)/kilogramconcentration-unit Bq/g becquerel(s)/gramconcentration-unit Bq/mg becquerel(s)/milligramconcentration-unit Bq/Aµg becquerel(s)/microgramconcentration-unit kBq/l kilobecquerel(s)/litreconcentration-unit kBq/ml kilobecquerel(s)/millilitreconcentration-unit kBq/Aµl kilobecquerel(s)/microlitreconcentration-unit MBq/l megabecquerel(s)/litreconcentration-unit MBq/ml megabecquerel(s)/millilitreconcentration-unit kBq/g kilobecquerel(s)/gramconcentration-unit kBq/mg kilobecquerel(s)/milligramconcentration-unit kBq/Aµg kilobecquerel(s)/microgramconcentration-unit MBq/kg megabecquerel(s)/kilogramconcentration-unit MBq/g megabecquerel(s)/gramconcentration-unit MBq/mg megabecquerel(s)/milligramconcentration-unit Ci/l curie(s)/litreconcentration-unit Ci/ml curie(s)/millilitreconcentration-unit Ci/Aµl curie(s)/microlitreconcentration-unit Ci/kg curie(s)/kilogramconcentration-unit Ci/g curie(s)/gramconcentration-unit Ci/mg curie(s)/milligramconcentration-unit Ci/Aµg curie(s)/microgramconcentration-unit mCi/l millicurie(s)/litreconcentration-unit mCi/ml millicurie(s)/millilitreconcentration-unit mCi/Aµl millicurie(s)/microlitreconcentration-type exact number

concentration-type rangeconcentration-type up toconcentration-type more thant-authorisation-identification Manufacturert-authorisation-identification Importert-authorisation-identification Boththerapeutic-area Diseases [C] - Bacterial Infections and Mycoses [C01]therapeutic-area Diseases [C] - Virus Diseases [C02]therapeutic-area Diseases [C] - Parasitic Diseases [C03]therapeutic-area Diseases [C] - Cancer [C04]therapeutic-area Diseases [C] - Musculoskeletal Diseases [C05]therapeutic-area Diseases [C] - Digestive System Diseases [C06]therapeutic-area Diseases [C] - Mouth and tooth diseases [C07]therapeutic-area Diseases [C] - Respiratory Tract Diseases [C08]therapeutic-area Diseases [C] - Ear, nose and throat diseases [C09]therapeutic-area Diseases [C] - Nervous System Diseases [C10]therapeutic-area Diseases [C] - Eye Diseases [C11]therapeutic-area Diseases [C] - Male diseases of the urinary and reproductive systetherapeutic-area Diseases [C] - Female diseases of the urinary and reproductive sytherapeutic-area Diseases [C] - Cardiovascular Diseases [C14]therapeutic-area Diseases [C] - Blood and lymphatic diseases [C15]therapeutic-area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and therapeutic-area Diseases [C] - Skin and Connective Tissue Diseases [C17]therapeutic-area Diseases [C] - Nutritional and Metabolic Diseases [C18]therapeutic-area Diseases [C] - Hormonal diseases [C19]therapeutic-area Diseases [C] - Immune System Diseases [C20]therapeutic-area Diseases [C] - Injuries, poisonings, and occupational diseases [C21therapeutic-area Diseases [C] - Symptoms and general pathology [C23]therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [therapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment [Etherapeutic-area Analytical, Diagnostic and Therapeutic Techniques and Equipment therapeutic-area Psychiatry and Psychology [F] - Behaviours [F01]therapeutic-area Psychiatry and Psychology [F] - Psychological processes [F02]therapeutic-area Psychiatry and Psychology [F] - Mental Disorders [F03]therapeutic-area Psychiatry and Psychology [F] - Behavioral Disciplines and Activitietherapeutic-area Body processes [G] - Physical Phenomena [G01]therapeutic-area Body processes [G] - Chemical Phenomena [G02]therapeutic-area Body processes [G] - Metabolic Phenomena [G03]therapeutic-area Body processes [G] - Cell Physiological Phenomena [G04]therapeutic-area Body processes [G] - Genetic Phenomena [G05]therapeutic-area Body processes [G] - Microbiological Phenomena [G06]therapeutic-area Body processes [G] - Physiological processes [G07]therapeutic-area Body processes [G] - Reproductive physiologi cal processes [G08]therapeutic-area Body processes [G] - Circulatory and Respiratory Physiological Ptherapeutic-area Body processes [G] - Digestive System and Oral Physiological Phtherapeutic-area Body processes [G] - Bones and nerves physological processes [Gtherapeutic-area Body processes [G] - Immune system processes [G12]therapeutic-area Body processes [G] - Integumentary System Physiological Phenomtherapeutic-area Body processes [G] - Ocular Physiological Phenomena [G14]therapeutic-area Body processes [G] - Biological Phenomena [G16]

therapeutic-area Body processes [G] - Mathematical Concepts [G17]therapeutic-area Health Care [N] - Population Characteristics [N01]therapeutic-area Health Care [N] - Health Care Facilities, Manpower, and Services [therapeutic-area Health Care [N] - Health Care Economics and Organizations [N03]therapeutic-area Health Care [N] - Health Services Administration [N04]therapeutic-area Health Care [N] - Health Care Quality, Access, and Evaluation [N05therapeutic-area Health Care [N] - Environment and Public Health [N06]opinion-status Pendingopinion-status Givenopinion-status To be requestedmsca-authorisation Not acceptedmsca-authorisation Accepted

review-competent-auth-status Authorised

review-competent-auth-status Refused

review-competent-auth-status Withdrawniec-opinion-status Favourableiec-opinion-status Not-Favourableiec-opinion-status Withdrawniec-opinion-separate-status Favourableiec-opinion-separate-status Not Favourableiec-opinion-separate-status Not Requiredamendment-referred Favourableamendment-referred Not Favourableamendment-referred Not Requiredamendment-authorisation Not Requiredamendment-authorisation Authorisedamendment-authorisation Refusedinspection-ctsite-site-type Clinical Investigatorinspection-ctsite-site-type Sponsorinspection-ctsite-site-type CROinspection-ctsite-site-type Laboratoryinspection-ctsite-site-type Othersponsor-status Commercialsponsor-status Non-Commercialconcentration-unit vector genomes (vg)/mL

Term Id999999000395999999000396999999000397999999000398999999000399999999000400999999000401999999000402999999000403999999000404999999000127999999000317999999000318999999000319999999000320999999000321999999000322999999000323999999000324999999000325999999000326999999000327999999000328999999000329999999000330999999000331999999000332999999000333999999000334999999000335999999000336999999000337999999000338999999000339999999000340999999000341999999000342999999000343999999000344999999000345999999000346999999000347999999000348999999000349999999000350999999000351999999000352999999000353999999000354999999000355999999000356999999000357999999000358

999999000359999999000360999999000361999999000362999999000363999999000364999999000365999999000366999999000367999999000368999999000369999999000370999999000371999999000372999999000373999999000374999999000375999999000376999999000377999999000378999999000379999999000380999999000381999999000382999999000383999999000384999999000385999999000386999999000387999999000388999999000412999999000001999999000002999999000003999999000004999999000005999999000006999999000007999999000008999999000009999999000010999999000011999999000012999999000013999999000014999999000015999999000016999999000017999999000018999999000019999999000020999999000021999999000022999999000023

999999000024999999000025999999000026999999000027999999000028999999000029999999000030999999000031999999000032999999000033999999000034999999000035999999000036999999000037999999000038999999000039999999000040999999000041999999000042999999000043999999000044999999000045999999000046999999000047999999000048999999000049999999000050999999000051999999000052999999000053999999000054999999000055999999000056999999000057999999000058999999000059999999000060999999000061999999000062999999000063999999000064999999000065999999000066999999000067999999000068999999000069999999000070999999000071999999000072999999000073999999000074999999000075999999000076999999000077

999999000078999999000079999999000080999999000081999999000082999999000083999999000084999999000085999999000086999999000087999999000088999999000089999999000090999999000091999999000092999999000093999999000094999999000095999999000096999999000097999999000098999999000099999999000100999999000101999999000102999999000103999999000104999999000105999999000106999999000107999999000108999999000109999999000110999999000111999999000112999999000113999999000114999999000115999999000168999999000169999999000170999999000171999999000172999999000173999999000174999999000175999999000176999999000177999999000178999999000179999999000180999999000181999999000182999999000183

999999000184999999000185999999000186999999000187999999000188999999000189999999000190999999000191999999000192999999000193999999000194999999000195999999000196999999000197999999000198999999000199999999000200999999000201999999000202999999000203999999000204999999000205999999000206999999000207999999000208999999000209999999000210999999000211999999000212999999000213999999000214999999000215999999000216999999000217999999000218999999000219999999000220999999000221999999000222999999000223999999000224999999000225999999000226999999000227999999000228999999000229999999000230999999000231999999000232999999000233999999000234999999000235999999000236999999000116

999999000117999999000118999999000119999999000392999999000393999999000394999999000422999999000423999999000424999999000425999999000426999999000427999999000428999999000429999999000430999999000431999999000432999999000433999999000434999999000435999999000436999999000437999999000438999999000439999999000440999999000441999999000442999999000443999999000444999999000445999999000446999999000447999999000448999999000449999999000450999999000451999999000452999999000453999999000454999999000455999999000456999999000457999999000458999999000459999999000460999999000461999999000462999999000463999999000464999999000465999999000466999999000467999999000468999999000469

999999000470999999000471999999000472999999000473999999000474999999000475999999000476999999000405999999000406999999000407999999000123999999000124

999999000477

999999000478

999999000479999999000480999999000481999999000482999999000483999999000484999999000485999999000128999999000129999999000130999999000389999999000125999999000126999999000133999999000134999999000135999999000136999999000137999999000410999999000411999999000689

Used where in EudraCT applicationWhat is the role of this investigator? In G.1 and G.2 Investigator DetailsWhat is the role of this investigator? In G.1 and G.2 Investigator DetailsWhat is the role of this investigator? In G.1 and G.2 Investigator DetailsC.1.1 and C.1.2 and C.1.3C.1.1 and C.1.2 and C.1.3C.1.1 and C.1.2 and C.1.3C.2.1 and C.2.2 and C.2.3 and C.2.4C.2.1 and C.2.2 and C.2.3 and C.2.4C.2.1 and C.2.2 and C.2.3 and C.2.4C.2.1 and C.2.2 and C.2.3 and C.2.4C.2.1 and C.2.2 and C.2.3 and C.2.4D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit), D.3.10.1 Concentration unitD.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)

D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)

D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)

D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)

D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)D.3.10.2 Concentration type

D.3.10.2 Concentration typeD.3.10.2 Concentration typeD.3.10.2 Concentration typeD.9.2.1 and D.9.2.2 As a manufacturer, importer or both?D.9.2.1 and D.9.2.2 As a manufacturer, importer or both?D.9.2.1 and D.9.2.2 As a manufacturer, importer or both?E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●

H.3.1 / H.3.2 / H.3.3 What is the status of the National Competent Authority's authorisation?H.3.1 / H.3.2 / H.3.3 What is the status of the National Competent Authority's authorisation?H.3.1 / H.3.2 / H.3.3 What is the status of the National Competent Authority's authorisation?H.3.3.2 / H.3.3.3 Indicate whether accepted or notH.3.3.2 / H.3.3.3 Indicate whether accepted or not

IEC Opinion of the trial application in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of the trial application in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of the trial application in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of amendment referred to in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of amendment referred to in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of amendment referred to in Section C of N. Review of the Clinical Trial ApplicationIEC Opinion of O. Application Amendment DetailsIEC Opinion of O. Application Amendment DetailsIEC Opinion of O. Application Amendment DetailsCA Authorisation/ Refusal of O. Application Amendment DetailsCA Authorisation/ Refusal of O. Application Amendment DetailsCA Authorisation/ Refusal of O. Application Amendment DetailsType of Site in Clinical Trial Site Inspection DetailsType of Site in Clinical Trial Site Inspection DetailsType of Site in Clinical Trial Site Inspection DetailsType of Site in Clinical Trial Site Inspection DetailsType of Site in Clinical Trial Site Inspection DetailsB.3.1 and B.3.2 Status of the sponsorB.3.1 and B.3.2 Status of the sponsorD.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit)

E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●E.1.1.2 Identify the therapeutic area●

CA Authorisation/ Refusal/ Withdrawal of the application in Section B of N. Review of the Clinical Trial ApplicationCA Authorisation/ Refusal/ Withdrawal of the application in Section B of N. Review of the Clinical Trial ApplicationCA Authorisation/ Refusal/ Withdrawal of the application in Section B of N. Review of the Clinical Trial Application

D.3.6.1 Specify total dose (number and unit), D.3.6.2 Specify total dose (number and unit), D.3.10.1 Concentration unit

LIST NAME IN EUTCT

reviewcycle

CountyIMP CategoryDosage Form

Rout of administrationDosage FormRout of administrationReview Reason where EudraCT Name is 'CA and IECReview ReasonInterruption or Completion Status where EudraCT NSubstantial Amendment TypeClinical Trial Inspection Status Clinical Trial Inspection Outcome

SECTION/AREA Used in CTA FormA.6 Is this a resubmission? Indicate the resubmission letter or else select 'First submission'

D.1.2 and D.1.3 Category●D.3.4 Pharmaceutical form●

D.8.3 Pharmaceutical form●D.8.4 Route of administration●Section A & Section B of N. Review of the Clinical Trial ApplicationSection C of N. Review of the Clinical Trial ApplicationSelect to add an interruption or completion for this trial in P. Interruptions and Completions of the Trial Type of Amendment in O. Application Amendment DetailsInspection status of Clinical Trial Site Inspection DetailsInspection outcome of Inspection Triggered / Outcome

B.1.3.4 Country, B.2.3.4 Country, B.4.2 Country, B.5.3.4 Country, C.1.4.3.4 Country, C.2.5.3.4 Country, D.2.1.2 The country which granted the Marketing Authorisation, D.9.2.4.4 Country

D.3.6.1 Route of administration (relevant to the first dose), D.3.6.2 Route of administration (relevant to the maximum dose), D.3.7 Routes of administration for this IMP

Two Digit alfa code to use in XML Languagebg Bulgarianhr Croatiancs Czechda Danishnl Dutchde German el Greek Modern (1453-)en Englishet Estonianfi Finnishfr French hu Hungarianga Irishit Italian lv Latvianlt Lithuanianmt Maltesepl Polishpt Portuguesero Romaniansk Slovaksl Slovenianes Spanishsv Swedish

NAME ORGANISATION_XML_IDGermany - PEI 21Germany - BfArM 22Austria - BASG 23Belgium - FPS Health-DGM 24Denmark - DKMA 25Finland - Fimea 26France - AFSSAPS 27Greece - EOF 28Ireland - IMB 29Italy - Italian Medicines Agency 30Luxembourg - Ministry of Health 31Netherlands - Competent Authority 33Portugal - INFARMED 34Spain - AEMPS 35Sweden - MPA 36UK - MHRA 37Norway - NOMA 38Czech Republic - SUKL 39Estonia - SAM 40Latvia - SAM 41Lithuania - SMCA 42Slovakia - SIDC (Slovak) 43Cyprus - MoH-Ph.S 44Iceland - IMCA 45Slovenia - ARSZMP 46Malta - MRU 47Poland - Office for Medicinal Products 48Hungary - National Institute of Pharmacy 49Liechtenstein - Kontrollstelle fur Arneimittel 82Bulgarian Drug Agency 121Romania - National Medicines Agency 122Croatia – MIZ 123