EMEA-000635-PIP01-09

Key facts

Active substance
Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)
Therapeutic area
Gastroentology-Hepatology
Decision number
P/20/2010
PIP number
EMEA-000635-PIP01-09
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
  • Treatment of anal fistula of Crohn´s disease associated aetiology
  • Treatment of anal fistula of cryptoglandular aetiology (Non-Crohn)
  • Treatment of non-inflammatory anal fistula
Route(s) of administration
Intralesional use
Contact for public enquiries
TiGenix S.A.U.
E-mail: info@tigenix.com
Tel: +34 918049264
Fax:+34 918049263
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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