ROUTES OF DRUG ADMINISTRATION
The route of administration is the way through which the dosage form is administered This route is called urethral route of drug administration.(10).
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Medication Administration 10/15-Hour Training Course for Adult
4 sept. 2013 0903 and 10A NCAC 13F/G .1000. 3. The routes of medication administration in this course include the following: oral eye
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ICH guideline E2B (R3) on electronic transmission of individual case
28 juil. 2013 G.k.10.r Additional information on drug (coded) (repeat as necessary). ... terminologies for routes of administration dosage forms and ...
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Estimating the Maximum Safe Starting Dose in Initial Clinical Trials
6 juil. 2005 This guidance represents the Food and Drug Administration's (FDA's) ... intranasal intratissue
ManageMent of Medication error reports associated with the
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Immunogenicity Assessment for Therapeutic Protein Products
10. 3. Route of Administration Dose
EudraVigilance User Manual - Individual Case Safety Report form
22 janv. 2018 European Medicines Agency 2018. ... Parent route of administration . ... element G.k.10.r [Additional Information on Drug (coded)].
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M 5 EWG Routes of administration - Controlled Vocabulary
Temporary TermID assigned to the Route of Administration within the controlled vocabulary (+). 3) ICH M5 Term = Route of Administration name valid at ICH
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ICH guideline M3(R2) on non-clinical safety studies for the conduct
For drugs for which the daily administered dose is <10 mammalian species using both the clinical and a parenteral route of administration. However such.
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NMBI Guidance for Registered Nurses and Midwives on Medication
11 août 2020 in medication administration. 10. Guiding principle 1. 10 ... 4.4 administer the medication via the prescribed anatomical route and site.
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Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
22 January 2018
EMA/249220/2016
Inspections, Human Medicines Pharmacovigilance & Committees Division EudraVigilance User ManualIndividual Case Safety Report
form Version 1.1EudraVigilance User Manual
EMA/249220/2016 Page 2/36
Contents
Contents
...................................................................................................... 2
Version ........................................................................................................ 4
Overview ..................................................................................................... 5
1. Introduction ............................................................................................ 5
1.1. General principles ................................................................................................. 5
2. Access to the ICSR form .......................................................................... 6
2.1. Access via Adrreports.eu portal .............................................................................. 7
2.2. Access via EVDAS ................................................................................................. 7
2.3. Access via EVWEB ................................................................................................ 9
3. Format and content of the ICSR form ...................................................... 9
3.1. General rules ....................................................................................................... 9
3.2. Nullflavors flags ................................................................................................. 10
3.3. Dynamism of the ICSR form ................................................................................ 10
3.4. Header .............................................................................................................. 12
3.5. General information ............................................................................................ 12
3.5.1. Worldwide Unique Case Identification Number ..................................................... 13
3.5.2. Sender"s organisation ....................................................................................... 13
3.5.3. Type of report ................................................................................................. 13
3.5.4. Primary Source Country ................................................................................... 13
3.5.5. Reporter"s qualification ..................................................................................... 14
3.5.6. Case serious? .................................................................................................. 14
3.5.7. Medically confirmed? ........................................................................................ 14
3.6. Patient .............................................................................................................. 14
3.6.1. Age ................................................................................................................ 14
3.6.2. Age group....................................................................................................... 15
3.7. Reaction / Event................................................................................................. 15
3.7.1. MedDRA LLT ................................................................................................... 15
3.7.2. Duration ......................................................................................................... 15
3.7.3. Seriousness .................................................................................................... 15
3.8. Drug information ................................................................................................ 17
3.8.1. Drug .............................................................................................................. 17
3.8.2. Role ............................................................................................................... 18
3.8.3. Duration ......................................................................................................... 19
3.8.4. Units in Interval
.............................................................................................. 193.8.5. Info ............................................................................................................... 19
3.8.6. Additional information on Drug
.......................................................................... 203.8.7. Indication ....................................................................................................... 20
3.8.8. Cumulative dose to first reaction ....................................................................... 20
3.8.9. Pharm. Form ................................................................................................... 20
3.8.10. Route of Admin.............................................................................................. 20
3.8.11. Parent route of administration ......................................................................... 20
3.9. Time-to-Onset and Rechallenge matrix table .......................................................... 21
EudraVigilance User Manual
EMA/249220/2016 Page 3/36
30 Churchill Place ł Canary Wharf ł London E14 5EU ł United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
22 January 2018
EMA/249220/2016
Inspections, Human Medicines Pharmacovigilance & Committees Division EudraVigilance User ManualIndividual Case Safety Report
form Version 1.1EudraVigilance User Manual
EMA/249220/2016 Page 2/36
Contents
Contents
...................................................................................................... 2
Version ........................................................................................................ 4
Overview ..................................................................................................... 5