A Non-interventional Post-authorisation Safety Study (PASS) as an Effectiveness Check of the Prescriber Checklist for Mycamine® (micafungin)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50179
• EU PAS number:
  EUPAS35011
• Study ID:
  50179
• Official title and acronym:
  A Non-interventional Post-authorisation Safety Study (PASS) as an Effectiveness Check of the Prescriber Checklist for Mycamine® (micafungin)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Greece

  Netherlands

  Poland

  Spain

  Sweden
• Study description:
  The overall goal of this study was to perform an effectiveness evaluation of the updated Prescriber Checklist (PC) for Mycamine among prescribers of Mycamine. The primary objectives of the study were to assess prescribers’ knowledge levels of: Potential risk of liver tumours associated with Mycamine, and the restricted indication for Mycamine (because of the potential risk of liver tumours, Mycamine should have only been used if other antifungals were not appropriate).
• Study status:
  Finalised

Research institution and networks

Institutions

ICON Commersialisation & Outcomes (MAPI-ICON), ICON

Germany

Study timelines

Date when funding contract was signed

Planned: 12/06/2019

Actual: 12/06/2019

Study start date

Planned: 18/05/2021

Actual: 30/06/2021

Date of final study report

Planned: 08/03/2022

Actual: 22/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe B.V.

Study protocol

Initial protocol

9463-PV-0002 Protocol v1.2 - Redacted

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)