Effectiveness of the Additional Risk Minimization Measures in Conveying Safety Information to HCPs Dispensing, Administering or Prescribing Fosphenytoin

Study identification

• EU PAS number:
  EUPAS27343
• Study ID:
  34474
• Official title and acronym:
  Effectiveness of the Additional Risk Minimization Measures in Conveying Safety Information to HCPs Dispensing, Administering or Prescribing Fosphenytoin
• DARWIN EU® study:
  No
• Study countries:
  France

  Sweden

  United Kingdom
• Study description:
  The overall objective is to evaluate the effectiveness of the additional RMMs being implemented across Europe to mitigate the risks of medication errors and off-label use in children under 5 years of age with the use fosphenytoin.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:19/06/2018

Actual:19/06/2018

Study start date

Planned:10/01/2019

Actual:25/02/2019

Date of final study report

Planned:04/09/2019

Actual:25/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

A9821002