EMEA-001406-PIP01-12

Key facts

Active substance
  • Mesalazine
  • prednisolone metasulphobenzoate
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0021/2014
PIP number
EMEA-001406-PIP01-12
Pharmaceutical form(s)
Rectal suspension
Condition(s) / indication(s)
Treatment of ulcerative colitis
Route(s) of administration
Rectal use
Contact for public enquiries
Disphar International B.V.
The Netherlands
E-mail: mcguinness@disphar.com
Tel. +31 3552 80400
Fax +31 3554 80585
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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