EMEA-001397-PIP04-17-M02 - paediatric investigation plan

Ibrutinib
PIPHuman

Key facts

Invented name
Imbruvica
Active Substance
Ibrutinib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0295/2023
PIP number
EMEA-001397-PIP04-17-M02
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 14602111
E-mail: contact@janssen-emea.com

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

Decision

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