MHRA-102372-PIP01-26

Key Facts

Active Substance
Active Substance:
  • Giredestrant
Invented Name
Not yet available
PIP Number MHRA-102372-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of breast malignant neoplasms
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07584264965
  • Email uk.dra@roche.com
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):Giredestrant.pdf
Published Date 06/07/2026