MHRA-101222-PIP01-23

Key Facts

Active Substance
Active Substance:
  • SJP-0132
Invented Name
Not yet available
PIP Number MHRA-101222-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Eye drops, suspension
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of Dry Eye Disease
Route(s) of administration
Route(s) of administration:
  • Ophthalmic use
PIP applicant
  • SENJU PHARMACEUTICAL COMPANY LIMITED
  • Country Japan
  • Tel +351308804284
  • Email andre.sousa@ppd.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):SJP-0132.pdf
Published Date 24/06/2024