EMEA-001397-PIP03-14-M03

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Overview

Product details for Imbruvica
Invented nameImbruvica
Active substance

Ibrutinib

Decision numberP/0398/2017
PIP numberEMEA-001397-PIP03-14-M03
Pharmaceutical form(s)Capsule, hard; Oral suspension
Condition(s)/indication(s)

Treatment of mature B-cell neoplasm

Route(s) of administrationOral use
PIP applicant

Janssen-Cilag International N.V.
Tel.: +49 2638 9479218
E-mail: sglawe@its.jnj.com
 

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

Decision