Status: Finalised First registered on: 26/09/2016
Last updated on: 10/10/2018
1. Study identification
EU PAS Register NumberEUPAS15507
Official titleDrug utilization study for Elvanse® / Tyvense® in Europe
Study title acronym
Study typeObservational study
Brief description of the studyThis is a multi-country drug utilization study using retrospective database analysis. A single database for all target countries is not available. Therefore, a study approach was chosen which includes multiple data sources to gather drug utilization data for Elvanse®/Tyvense® in European target countries. The study’s objective is to provide data on an annual basis for up to 5 years.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 groupIQVIA Real World Insights
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name von Bredow
First name Dorothea
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

Denmark
Finland
Germany
Ireland
Norway
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/07/2013
Start date of data collection21/02/2014
Start date of data analysis24/02/2014
Date of interim report, if expected09/04/2014
Date of final study report31/03/201812/04/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShire Pharmaceuticals100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Siffel
First name Csaba
Address line 1300 Shire Way
Address line 2Shire 
Address line 3 
CityLexington 
PostcodeMA 02421 
CountryUnited States
Phone number (incl. country code)1-781-2663672 
Alternative phone number 
Fax number (incl. country code) 
Email address csiffel0@shire.com
Public Enquiries
Title Dr 
Last name Siffel 
First name Csaba 
Address line 1300 Shire Way 
Address line 2Shire 
Address line 3 
CityLexington 
PostcodeMA 02421 
CountryUnited States 
Phone number (incl. country code)1-781-2663672 
Alternative phone number 
Fax number (incl. country code) 
Email address csiffel0@shire.com 
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