Page contents Key factsDecisionKey facts Active Substance tifcemalimab Therapeutic area Neoplasms benign, malignant and unspecified (incl cysts and polyps) Decision number P/0016/2024 PIP number EMEA-003512-PIP01-23 Pharmaceutical form(s) All pharmaceutical forms Condition(s) / indication(s) Treatment of lung cancer (small cell and non-small cell lung cancer) Route(s) of administration All routes of administration Contact for public enquiries E-mail: regulatory@topalliancebio.comTel. +13 016 405 166 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 06/02/2024DecisionP/0016/2024 : EMA decision of 6 February 2024 on the granting of a product specific waiver for tifcemalimab (EMEA-003512-PIP01-23)AdoptedReference Number: EMA/15348/2024 English (EN) (208.38 KB - PDF)First published: 26/03/2025ViewShare this page