Assessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19830
• EU PAS number:
  EUPAS8408
• Study ID:
  19830
• Official title and acronym:
  Assessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  On the 11 of July 2011, EMA approved a label change for Pioglitazone that included new labelling on haematuria, bladder cancer and guidance on monitoring treatment effectiveness. A Dear Healthcare Provider Communication (DHPC) letter was sent to Danish prescribers on 11 August 2011 informing them of the label change. This drug utilisation study (DUS) aims to assess compliance with prescribing information in Denmark following the July 2011 labelling changes.
• Study status:
  Finalised

Research institution and networks

Institutions

Evidera

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 06/02/2015

Actual: 06/02/2015

Study start date

Planned: 01/07/2015

Actual: 08/11/2015

Data analysis start date

Planned: 01/03/2016

Actual: 01/03/2016

Date of final study report

Planned: 29/07/2016

Actual: 27/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Europe

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)