Page contentsKey factsDecisionKey facts Active Substance Batoclimab Therapeutic area Ophthalmology Decision number P/0452/2022 PIP number EMEA-003162-PIP02-22 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of thyroid eye disease Route(s) of administration Subcutaneous use Contact for public enquiries Immunovant Sciences, GmbHE-mail: regulatoryaffairs@immunovant.comTel. +1 3174175110 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 28/10/2022DecisionP/0452/2022: EMA decision of 28 October 2022 on the granting of a product specific waiver for batoclimab (EMEA-003162-PIP02-22)AdoptedReference Number: EMA/834765/2022 English (EN) (177.96 KB - PDF)First published: 04/10/2023ViewShare this page