EMEA-001205-PIP02-19-M02 - paediatric investigation plan

Tecovirimat (monohydrate)

Key facts

• Active Substance:
  Tecovirimat (monohydrate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0540/2022
• PIP number:
  EMEA-001205-PIP02-19-M02
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  SIGA Technologies, Inc.

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0540/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tecovirimat (monohydrate) (Tecovirimat SIGA), (EMEA-001205-PIP02-19-M02)

AdoptedReference Number: EMA/876002/2022