EMA study on prescribing of ibuprofen in the French primary care setting

Study identification

• EU PAS number:
  EUPAS8075
• Study ID:
  14400
• Official title and acronym:
  EMA study on prescribing of ibuprofen in the French primary care setting
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The present study has been undertaken in the context of the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) Article 31 review to evaluate the cardiovascular risks with systemic ibuprofen medicines. These risks concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time. The primary objective of the present analysis is to provide drug utilisation data on the exposure of high-dose ibuprofen prescribing (2,400 mg or above per day) in France in adults.Furthermore, the duration of the prescription will be calculated to estimate the percentage of patients prescribed high-dose ibuprofen for long periods. This analysis includes all patients recorded in the France IMS database as having received a prescription of ibuprofen.The study period includes all data available in IMS France, from 1st January 1997 to 30th June 2014.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:01/11/2014

Actual:01/11/2014

Study start date

Planned:03/11/2014

Actual:03/11/2014

Date of final study report

Planned:14/11/2014

Actual:14/11/2014

Sources of funding

Other

More details on funding

Conducted using EMA resources

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable