A Non interventional post authorisation study to determine the safety and effectiveness of flutiform® (Affirm Study). (FLT9503 AFFIRM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23261
• EU PAS number:
  EUPAS4072
• Study ID:
  23261
• Official title and acronym:
  A Non interventional post authorisation study to determine the safety and effectiveness of flutiform® (Affirm Study). (FLT9503 AFFIRM)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Denmark

  France

  Ireland

  Norway

  Slovakia

  Sweden

  United Kingdom
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bispebjerg and Frederiksberg Hospital

Department of Clinical Medicine,Section of Orthopaedics and Internal Medicine

Study timelines

Date when funding contract was signed

Actual: 04/06/2013

Study start date

Planned: 02/09/2013

Actual: 20/11/2013

Date of interim report, if expected

Planned: 31/05/2016

Date of final study report

Planned: 31/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mundipharma Research Ltd

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)