Safety Alerts: An Observational Study in Portugal (Safety alerts)

Study identification

• EU PAS number:
  EUPAS11977
• Study ID:
  17084
• Official title and acronym:
  Safety Alerts: An Observational Study in Portugal (Safety alerts)
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  An observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was extracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Medical Sciences Institute of Biomedicine, University of Aveiro

Portugal

Study timelines

Date when funding contract was signed

Planned: 17/09/2012

Actual: 17/09/2013

Study start date

Planned: 07/01/2013

Actual: 04/02/2013

Date of final study report

Planned: 01/07/2015

Actual: 15/07/2015

Sources of funding

Other

More details on funding

Internal funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable