EMEA-000575-PIP01-09-M03 - paediatric investigation plan

ciclosporin
PIPHuman

Key facts

Active Substance
ciclosporin
Therapeutic area
Ophthalmology
Decision number
P/0142/2015
PIP number
EMEA-000575-PIP01-09-M03
Pharmaceutical form(s)
Eye drops, emulsion
Condition(s) / indication(s)
  • Treatment of keratoconjunctivitis sicca
  • Treatment of vernal keratoconjunctivitis
Route(s) of administration
Ocular use
Contact for public enquiries

Santen SAS

France
Tel. +33 169874020
E-mail: mohamed.ibrahiem@santen.fr

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000575-PIP01-09-M03
Compliance opinion date
Compliance outcome
Positive

Decision

Share this page