EMEA-002218-PIP01-17 - paediatric investigation plan

anti-mucosal addressin cell adhesion molecule antibody (SHP647)

Key facts

• Active substance:
  anti-mucosal addressin cell adhesion molecule antibody (SHP647)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0281/2018
• PIP number:
  EMEA-002218-PIP01-17
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/09/2018
• Compliance check done:
  No

Decision

P/0281/2018: EMA decision of 12 September 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-mucosal addressin cell adhesion molecule antibody (SHP647), (EMEA-002218-PIP01-17

Reference Number: EMA/517239/2018