A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev (Nintedanib, 150mg/100mg, BID) in Korean patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47414
• EU PAS number:
  EUPAS41912
• Study ID:
  47414
• Official title and acronym:
  A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev (Nintedanib, 150mg/100mg, BID) in Korean patients
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 31/12/2020

Actual: 29/12/2020

Study start date

Planned: 31/03/2021

Actual: 16/03/2021

Date of final study report

Planned: 20/07/2023

Actual: 27/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Korea

Study protocol

Initial protocol

1199-0417_CTP_final-rule_Redacted.pdf

Regulatory

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

Other study registration identification numbers and links

1199-0417