MHRA-100884-PIP01-23-M01 (update)

Key Facts

Active Substance
  • SACUBITRIL
  • VALSARTAN
Invented Name
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
PIP Number MHRA-100884-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate solid oral dosage form
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of Heart failure
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
27/03/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100884-PIP01-23-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SACUBITRILVALSARTAN.pdf
Published Date 25/05/2023