Post Authorization Safety Study: Knowledge about safety precautions among physicians in Denmark prescribing CPA/EE products

Study identification

• EU PAS number:
  EUPAS11414
• Study ID:
  14684
• Official title and acronym:
  Post Authorization Safety Study: Knowledge about safety precautions among physicians in Denmark prescribing CPA/EE products
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  The study first included a DUS study. Objective: Indications for prescribing CPA/EE products among physicians in Denmark. To collect information about the indications physicians use for prescribing CPA/EE products in current clinical practice in Denmark.PASS objective: To collect information about physicians’ knowledge of contraindications and the key safety precautions to be observed when prescribing CPA/EE products in current clinical practice in Denmark.
• Study status:
  Finalised

Research institutions and networks

Institutions

Orifarm Generics

Study timelines

Date when funding contract was signed

Planned: 24/10/2014

Actual: 24/10/2014

Study start date

Planned: 01/03/2015

Actual: 02/03/2015

Date of final study report

Planned: 01/05/2015

Actual: 20/04/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orifarm Generics A/S

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)