EMEA-001397-PIP03-14-M05

Table of contents

Key facts

Invented name
Imbruvica
Active substance
Ibrutinib
Therapeutic area
Oncology
Decision number
P/0117/2021
PIP number
EMEA-001397-PIP03-14-M05
Pharmaceutical form(s)
  • Film-coated tablet
  • 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.

E-mail: nreymond@its.jnj.com
Tel.: +31 14641125

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

Decision

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