MHRA-102064-PIP01-25-M01 (update)

Key Facts

Active Substance
Active Substance:
  • MERCAPTAMINE HYDROCHLORIDE
Invented Name
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
PIP Number MHRA-102064-PIP01-25-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Eye drops, solution
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of cystinosis.
Route(s) of administration
Route(s) of administration:
  • Ocular 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
06/08/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-102064-PIP01-25-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MERCAPTAMINE HYDROCHLORIDE.pdf
Published Date 11/09/2025