Leuprorelin and medication error and lack of effect - An analysis of EudraVigilance

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39126
• EU PAS number:
  EUPAS39125
• Study ID:
  39126
• Official title and acronym:
  Leuprorelin and medication error and lack of effect - An analysis of EudraVigilance
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This was a descriptive study of case reports of medication errors and lack of efficacy reported to leuprorelin to EudraVigilance.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 19/06/2019

Actual: 19/06/2019

Study start date

Planned: 19/06/2019

Actual: 19/06/2019

Data analysis start date

Planned: 19/06/2019

Actual: 19/06/2019

Date of final study report

Planned: 02/08/2019

Actual: 31/07/2019

Sources of funding

EMA

Regulatory

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