Severe hypersensitivity reactions associated with high dose iv iron containing medicinal products

Study identification

• EU PAS number:
  EUPAS25192
• Study ID:
  28647
• Official title and acronym:
  Severe hypersensitivity reactions associated with high dose iv iron containing medicinal products
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Latvia

  Lithuania

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  Evaluation of severe hypersensitivity reactions after administration of high dose iv irons with respect to overall exposure in European countries by using information from existing data sources
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Actual:08/03/2018

Study start date

Planned:15/06/2018

Actual:02/07/2018

Data analysis start date

Planned:02/07/2018

Actual:16/07/2018

Date of final study report

Planned:31/12/2018

Actual:12/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Vifor International AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable