Severe hypersensitivity reactions associated with i.v. iron containing medicinal products in countries of the European Economic Area – before and after implementation of risk minimisation measures

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30103
• EU PAS number:
  EUPAS27963
• Study ID:
  30103
• Official title and acronym:
  Severe hypersensitivity reactions associated with i.v. iron containing medicinal products in countries of the European Economic Area – before and after implementation of risk minimisation measures
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Iceland

  Ireland

  Italy

  Latvia

  Lithuania

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Spain

  Sweden

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

Research institution and networks

Institutions

IQVIA

United Kingdom

N/A

Study timelines

Date when funding contract was signed

Actual: 06/11/2018

Study start date

Planned: 26/11/2018

Actual: 26/11/2018

Data analysis start date

Planned: 07/12/2018

Actual: 17/12/2018

Date of final study report

Planned: 15/02/2019

Actual: 19/02/2019

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