Page contentsPage contents Key facts Decision Key facts Active substance rocatinlimab Therapeutic area Skin and subcutaneous tissue disorders Decision number P/0264/2023 PIP number EMA/PE/0000230710 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of atopic dermatitis Route(s) of administration Subcutaneous use Contact for public enquiries Kyowa Kirin Holdings B.V. Tel. +44 (0)1896 664000E-mail: regulatorygroup@kyowakirin.com Decision type PM: decision on the application for modification of an agreed PIP Decision date 19/02/2025 Compliance check done No Decision EMA/PE/0000230710 : EMA decision of 19 February 2025 on the acceptance of a modification of an agreed paediatric investigation plan for rocatinlimabAdopted Reference Number: EMADOC-1700519818-1880424 English (EN) (240.89 KB - PDF)First published: 07/05/2026 View Share this page