Cyproterone-containing medicines and Meningiomas - An EudraVigilance analysis

Study identification

• EU PAS number:
  EUPAS39144
• Study ID:
  39145
• Official title and acronym:
  Cyproterone-containing medicines and Meningiomas - An EudraVigilance analysis
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This was a descriptive study of meningiomas reported to cyproterone-containing medicines using EudraVigilance data.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:01/08/2019

Actual:01/08/2019

Study start date

Planned:01/08/2019

Actual:01/08/2019

Data analysis start date

Planned:01/08/2019

Actual:01/08/2019

Date of interim report, if expected

Planned:02/09/2019

Actual:26/09/2019

Date of final study report

Planned:12/09/2019

Actual:04/10/2019

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