Last updated on: 04/04/2012
1. Contact details
Name of data sourceEudraVigilance
Name under which the data source should be displayed in the inventory (e.g short name if one exists)EudraVigilance
Name of organisation
1) Department/research groupPharmacovigilance and Risk management Sector
2) Organisation/affiliationEuropean Medicines Agency
Administrative Contact
Title Mr
Last name Slattery
First name Jim
Address line 17 Westferry Circus
Address line 2Canary Wharf
Address line 3
CityLONDON
PostcodeE14 4HB
CountryUnited Kingdom
Scientific Contact
Title Mr
Last name Slattery
First name Jim
Address line 17 Westferry Circus
Address line 2Canary Wharf
Address line 3
CityLONDON
PostcodeE14 4HB
CountryUnited Kingdom
Alternative Contact
Title Mr
Last name Alcini
First name Paolo
Address line 17 Westferry Circus
Address line 2Canary Wharf
Address line 3
CityLONDON
PostcodeE14 4HB
CountryUnited Kingdom
2. Description/category
Spontaneous reporting database
3.1 Coverage of licensed medicinal products
Licensed Medicinal Product
Comments
Hospital data
Community / general practice data
OTC
Vaccines
3.2 ATC code (5th level)
No
3.3 Other product dictionaries
EV Medicinal Product Dictionary
3.4 Recording of indication for use
No
4. Coverage of events
Event
Dictionary
Dictionary details
Adverse events (for pharmacovigilance databases)
Yes
MedDRA
5. Year of establishment
2001
6. Geographical origin of data
EEA/EFTA countries
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Republic of Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
Non EEA/EFTA areas
Non EEA Europe (excluding Russia & former Soviet Republics)
Russia & former Soviet Republics
Middle East
Asia
North America
Central America & Caribbean
South America
Africa
Australia & Oceania
7. Demographical extent of data collection
Nation-wide
8. Age groups
17 years and under [Paediatrics]
preterm newborn infants
term newborn infants (0 to 27 days)
infants and toddlers (28 days to 23 months)
children (2 to 11 years)
adolescents (12 to 17 years)
18 to 45 years
46 to 64 years
65 years and over
65 to 75 years
76 years and over
9. Size of the source/catchment population
7,000,000,000
10 a. Total (cumulative) number of persons with actual data
2,100,000
10 b. Number of persons with active data collection in past calendar year
360,000
11. Possibility to obtain additional information on the patient
a) Clinical information from treating physician?
No
b) Questionnaire data from the patient?
No
c) Genetic information or samples?
No
12. Possibility of links to other sources of data
No
13. Written policy governing data access
Yes
14. Committee to evaluate requests for data access
Yes
15. Charge/fee for data access
No
16. Selected publications of the last 5 calendar years using data from this data source
ReferenceLink to web-publication
Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance.
Kurz X, Domergue F, Slattery J, Segec A, Szmigiel A, Hidalgo-Simon A.
Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.
Alvarez Y, Hidalgo A, Maignen F, Slattery J.
