MHRA-100162-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • SELEXIPAG
Invented Name
  • Uptravi
  • Uptravi
  • Uptravi
PIP Number MHRA-100162-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Tablet
Therapeutic area
Therapeutic area:
  • Other: Pulmonary heart disease and diseases of pulmonary circulation
Conditions / Indications
Conditions / Indications:
  • Treatment of pulmonary arterial hypertension (PAH)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
09/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100162-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SELEXIPAG.pdf
Published Date 19/12/2023