PASS TachoSil Evaluation (PasTel): Short- and long-term safety evaluation of TachoSil in paediatric population

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000505
• EU PAS number:
  EUPAS1000000505
• Study ID:
  1000000505
• Official title and acronym:
  PASS TachoSil Evaluation (PasTel): Short- and long-term safety evaluation of TachoSil in paediatric population
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Actual: 05/08/2024

Study start date

Planned: 31/12/2024

Date of final study report

Planned: 30/06/2029

Sources of funding

Pharmaceutical company and other private sector 

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)