EMEA-000459-PIP01-08-M02

Key facts

Invented name
Resolor
Active substance
Prucalopride succinate
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0293/2012
PIP number
EMEA-000459-PIP01-08-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
Condition(s) / indication(s)
  • Treatment of opioid-induced constipation
  • Treatment of chronic constipation
Route(s) of administration
Oral use
Contact for public enquiries
Shire-Movetis NV
E-mail: paediatrics@shire.com
Belgium 
Tel. +32 14404390
Fax +32 14404391
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000459-PIP01-08-M02
Compliance opinion date
06/12/2013
Compliance outcome
positive

Decision

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