MHRA-100335-PIP01-21

Key Facts

Active Substance
Active Substance:
  • erdafitinib
Invented Name
  • BALVERSA
  • BALVERSA
  • ERFANDEL
  • BALVERSA
PIP Number MHRA-100335-PIP01-21
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):erdafitinib .pdf
Published Date 27/09/2022