EMEA-001397-PIP03-14-M04

Key facts

Invented name
Imbruvica
Active substance
Ibrutinib
Therapeutic area
Oncology
Decision number
P/0201/2019
PIP number
EMEA-001397-PIP03-14-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral suspension
  • Capsule, hard
Condition(s) / indication(s)
Treatment of mature B-cell neoplasms
Route(s) of administration
Oral 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

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