Annual investigate of EMEND prescription

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19569
• EU PAS number:
  EUPAS5333
• Study ID:
  19569
• Official title and acronym:
  Annual investigate of EMEND prescription
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  EMEND® (aprepitant) is an anti-emetic drug indicated for the prevention of nausea and vomiting associated with acute and delayed highly emetogenic cancer chemotherapy including cisplatin, and with moderately emetogenic chemotherapy.Annual monitoring of the conditions of use of this drug has been requested to MSD France laboratory by the Transparency Committee and the Economic Committee for Health Products.Using Onco-Analyser/IMS Health database, the objective of the study is to check EMEND® compliance in real life: profile of patients, type of cancer, chemotherapy and/or other previous treatments, daily dose, duration of treatment and associated treatments, and to make an annual follow-up of the respect of the conditions of use of EMEND® in comparison with the Therapeutic Information Sheet, over 8 years.
• Study status:
  Finalised

Research institutions and networks

Institutions

Université Claude Bernard Lyon 1

Study timelines

Date when funding contract was signed

Actual: 14/01/2005

Study start date

Actual: 01/09/2005

Date of final study report

Planned: 28/02/2014

Actual: 15/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD FRANCE

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable