EMEA-001397-PIP04-17

Key facts

Invented name
Imbruvica
Active substance
Ibrutinib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0021/2019
PIP number
EMEA-001397-PIP04-17
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.  +44 1494567593
E-mail: EJones9@its.jnj.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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