Post-Marketing Surveillance of REGKIRONA ® 960mg (Regdanvimab)(monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy (CT-P59 4.1)

Study identification

• EU PAS number:
  EUPAS46141
• Study ID:
  46142
• Official title and acronym:
  Post-Marketing Surveillance of REGKIRONA ® 960mg (Regdanvimab)(monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy (CT-P59 4.1)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  Post-Marketing Surveillance of REGKIRONA 960 mg (Regdanvimab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy. The regimen and dosage of Regdanvimab shall follow that of approved by Ministry of Food and Drug Safety in Korea. The objectives of this post-marketing surveilance (PMS) are to evaluate the safety and efficacy of regdanvimab in Korea under routine care.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Celltrion

Study timelines

Date when funding contract was signed

Actual: 03/03/2021

Study start date

Actual: 03/03/2021

Date of final study report

Planned: 08/02/2027

Sources of funding

EU institutional research programme

More details on funding

Celltrion Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)