EMEA-000575-PIP01-09-M03

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
Compliance procedure number
EMEA-C-000575-PIP01-09-M03
Compliance opinion date
29/04/2016
Compliance outcome
positive

Decision

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