Drug Utilization Study on the Risk Minimisation Tools for Sialanar

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24636
• EU PAS number:
  EUPAS24635
• Study ID:
  24636
• Official title and acronym:
  Drug Utilization Study on the Risk Minimisation Tools for Sialanar
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned: 28/12/2017

Actual: 28/12/2017

Study start date

Planned: 01/01/2018

Data analysis start date

Planned: 01/12/2021

Date of final study report

Planned: 01/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Proveca Ltd

Study protocol

Initial protocol

Sialanar DUS PRO_GLY_004 v5.0 20180321

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)