RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24438
• EU PAS number:
  EUPAS20197
• Study ID:
  24438
• Official title and acronym:
  RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Actual: 10/02/2016

Study start date

Planned: 19/02/2016

Actual: 19/02/2016

Date of final study report

Actual: 15/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development (JRD)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)