Study of the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel with a maximum dose of 300 IR daily in routine application in adults (GO FOR 300)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43256
• EU PAS number:
  EUPAS43255
• Study ID:
  43256
• Official title and acronym:
  Study of the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel with a maximum dose of 300 IR daily in routine application in adults (GO FOR 300)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Switzerland
• Study description:
  International, prospective, open-label, multicentric, non-interventional Post Authorization Safety Study (PASS) in adults to further describe the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel at a maximum dose of 300 IR/daily in routine practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Stallergenes

Study timelines

Date when funding contract was signed

Planned: 22/07/2020

Actual: 22/07/2020

Study start date

Planned: 15/09/2020

Actual: 19/10/2020

Data analysis start date

Planned: 15/01/2023

Date of final study report

Planned: 30/09/2023

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