Study of the safety and tolerability of ORYLMYTE in routine practice in adolescents and adults (VORAN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44429
• EU PAS number:
  EUPAS44205
• Study ID:
  44429
• Official title and acronym:
  Study of the safety and tolerability of ORYLMYTE in routine practice in adolescents and adults (VORAN)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Prospective, open-label, multicentre, non-interventional, longitudinal Post Authorization Safety Study (PASS) in adolescents (12-17 years) and adults to further describe the safety and tolerability of ORYLMYTE
• Study status:
  Ongoing

Research institutions and networks

Institutions

Stallergenes

Study timelines

Date when funding contract was signed

Planned: 28/06/2021

Actual: 28/06/2021

Study start date

Planned: 15/10/2021

Actual: 12/11/2021

Data analysis start date

Planned: 15/01/2024

Date of final study report

Planned: 15/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Stallergenes GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable