MHRA-100648-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TECOVIRIMAT MONOHYDRATE
Invented Name
  • Tecovirimat SIGA
  • Tecovirimat SIGA
  • TPOXX
PIP Number MHRA-100648-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Powder for oral suspension
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)
Route(s) of administration
  • Oral use
  • Gastric use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TECOVIRIMAT MONOHYDRATE.pdf
Published Date 02/02/2023