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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34474
• 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 institution 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

Study protocol

Initial protocol

FOSPHENYTOIN_DRAFT PROTOCOL VS5 FINAL VS4

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