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

• PURI:
  https://redirect.ema.europa.eu/resource/50574
• 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 institution 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

Study protocol

Initial protocol

Oral Retinoids PASS DUS protocol v3.0 Redacted_No Annex

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)