Drug utilization study for Elvanse® / Tyvense® / Elvanse® Adult in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44400
• EU PAS number:
  EUPAS15507
• Study ID:
  44400
• Official title and acronym:
  Drug utilization study for Elvanse® / Tyvense® / Elvanse® Adult in Europe
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Germany

  Ireland

  Norway

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Actual: 24/07/2013

Study start date

Actual: 21/02/2014

Data analysis start date

Actual: 24/02/2014

Date of interim report, if expected

Actual: 09/04/2014

Date of final study report

Planned: 31/03/2018

Actual: 12/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shire Pharmaceuticals

Study protocol

Initial protocol

SHP489-813 Elvanse DUS Protocol Version 3.0_26Feb2018 _clean_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)