Page contents Key factsDecisionKey facts Active Substance Erdafitinib Therapeutic area Neoplasms benign, malignant and unspecified (incl cysts and polyps) Decision number P/0145/2024 PIP number EMEA-002042-PIP03-23 Pharmaceutical form(s) Tablet Condition(s) / indication(s) Treatment of urothelial carcinoma Route(s) of administration Intravesical use Contact for public enquiries Janssen Cilag International Email: contact@Janssen-emea.com Tel. +32 14602111 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 06/05/2024DecisionP/0145/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for erdafitinib (EMEA-002042-PIP03-23)Reference Number: EMA/155774/2024 English (EN) (177.14 KB - PDF)First published: 06/06/2025ViewShare this page