Post Marketing Surveillance Study for Mircera

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20705
• EU PAS number:
  EUPAS4683
• Study ID:
  20705
• Official title and acronym:
  Post Marketing Surveillance Study for Mircera
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  This study (ML22560) is a post-marketing prospective surveillance study (conducted in Korea from 29 Aug 2008 to 28 Aug 2012) to meet local regulatory requirements.
• Study status:
  Finalised

Research institution and networks

Institutions

F. Hoffmann-La Roche

Multiple centres: 26 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/01/2008

Study start date

Actual: 29/08/2008

Data analysis start date

Actual: 28/08/2012

Date of final study report

Actual: 28/11/2012

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche

Regulatory

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

Other study registration identification numbers and links

ML22560