Key facts

Active Substance
Naldemedine
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0379/2021
PIP number
EMEA-001893-PIP01-15-M02
Pharmaceutical form(s)
  • Tablet
  • Powder for oral suspension
Condition(s) / indication(s)
Treatment of opioid-induced constipation (OIC)
Route(s) of administration
Oral use
Contact for public enquiries

Shionogi Limited

E-mail: shionogiclintrials-admin@shionogi.co.jp
Tel. +44 (0)20 3534 200

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0379/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for naldemedine (EMEA-001893-PIP01-15-M02)

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