PATTERN OF USE AND SAFETY PROFILE OF BRANDED VS GENERIC ANTIEPILEPTIC DRUGS

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44414
• EU PAS number:
  EUPAS24224
• Study ID:
  44414
• Official title and acronym:
  PATTERN OF USE AND SAFETY PROFILE OF BRANDED VS GENERIC ANTIEPILEPTIC DRUGS
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study status:
  Finalised

Research institutions and networks

Institutions

Unit of adverse drug reactions monitoring (UADRM), University Hospital of Pisa

Italy

Neurofarba Department, Pharmacovigilance Unit, University of Florence

Italy

Unit of adverse drug reactions monitoring (UADRM), University Hospital of Pisa

Italy

Study timelines

Date when funding contract was signed

Planned: 01/06/2018

Actual: 01/06/2018

Study start date

Planned: 01/06/2018

Actual: 01/06/2018

Data analysis start date

Planned: 11/06/2018

Date of final study report

Planned: 28/09/2018

Actual: 18/02/2021

Sources of funding

Other

More details on funding

University of Florence

Study protocol

Initial protocol

Project AEDs

Regulatory

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