Page contentsKey factsDecisionRelated contentKey factsInvented nameImbruvicaImbruvicaActive SubstanceIbrutinibTherapeutic areaOncologyDecision numberP/0297/2017PIP numberEMEA-001397-PIP06-17Pharmaceutical form(s)Film-coated tabletCondition(s) / indication(s)Treatment of lymphoplasmacytic lymphomaRoute(s) of administrationOral useContact for public enquiriesJanssen-Cilag International N.V.Tel. +32 1 464 1125E-mail: JWeemer1@its.jnj.comDecision typeW: decision granting a waiver in all age groups for all conditions or indicationsDecision date04/10/2017DecisionP/0297/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for ibrutinib (Imbruvica) (EMEA-001397-PIP06-17)Reference Number: EMA/635149/2017 English (EN) (74.21 KB - PDF)First published: 12/02/2018Last updated: 12/02/2018ViewRelated contentImbruvicaShare this pageHow useful do you find this page?12345