Page contentsKey factsDecisionKey facts Active Substance Sacituzumab govitecan Therapeutic area Oncology Decision number P/0398/2020 PIP number EMEA-002645-PIP02-20 Pharmaceutical form(s) Powder and solvent for solution for infusion Condition(s) / indication(s) Treatment of urothelial carcinoma Route(s) of administration Intravenous use Contact for public enquiries Immunomedics GmbHE-mail: Regulatory.Pip@gilead.comTel: +44 1223897300 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 23/10/2020DecisionP/0398/2020 : EMA decision of 23 October 2020 on the granting of a product-specific waiver for sacituzumab govitecan (EMEA-002645-PIP02-20)AdoptedReference Number: EMA/494619/2020 English (EN) (228.28 KB - PDF)First published: 09/09/2021ViewShare this page