Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilization study (DUS) using secondary data

Study identification

• EU PAS number:
  EUPAS32302
• Study ID:
  50574
• Official title and acronym:
  Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilization study (DUS) using secondary data
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned:30/06/2018

Actual:30/11/2018

Study start date

Planned:01/07/2021

Actual:08/10/2021

Data analysis start date

Planned:03/01/2022

Actual:04/02/2022

Date of final study report

Planned:31/12/2022

Actual:02/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Oral Retinoids Consortium consisting of 34 Marketing Authorisation Holders

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)