Status: Finalised First registered on: 08/08/2018
Last updated on: 01/03/2019
1. Study identification
EU PAS Register NumberEUPAS25192
Official titleSevere hypersensitivity reactions associated with high dose iv iron containing medicinal products
Study title acronym
Study typeOther: Pharmacoepidemiologic study with case-population design
Brief description of the studyEvaluation of severe hypersensitivity reactions after administration of high dose iv irons with respect to overall exposure in European countries by using information from existing data sources
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Annegret
First name Gohlke
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Austria
Belgium
Bulgaria
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/03/2018
Start date of data collection15/06/201802/07/2018
Start date of data analysis02/07/201816/07/2018
Date of interim report, if expected
Date of final study report31/12/201812/02/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesVifor International AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Ehlken
First name Birgit
Address line 1Landshuter Allee 10
Address line 2 
Address line 3 
CityMunich 
Postcode80637 
CountryGermany
Phone number (incl. country code)49-894579126400 
Alternative phone number 
Fax number (incl. country code) 
Email address behlken@de.imshealth.com
Public Enquiries
Title Mrs 
Last name Birgit 
First name Ehlken 
Address line 1Landshuter Allee 10 
Address line 2 
Address line 3 
CityMunich 
Postcode80637 
CountryGermany 
Phone number (incl. country code)49-89-4579126400 
Alternative phone number 
Fax number (incl. country code) 
Email address behlken@de.imshealth.com 
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