Key facts

Invented name
  • undefined
  • Imbruvica
Active Substance
Ibrutinib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0421/2019
PIP number
EMEA-001397-PIP04-17-M01
Pharmaceutical form(s)
  • Capsule (hard)
  • Film-coated tablet
  • Oral suspension
Condition(s) / indication(s)
Treatment of chronic Graft versus Host Disease (cGvHD)
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries

Janssen-Cilag International N.V.

Tel. +32 1 464 1125
E-mail: JWeemer1@its.jnj.com

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

Decision

P/0421/2019: EMA decision of 6 December 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica), (EMEA-001397-PIP04-17-M01)

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