Page contentsPage contents Key facts Decision Key facts Active substance amlitelimab Therapeutic area Skin and subcutaneous tissue disorders Decision number EMA/PE/0000182447 PIP number EMA/PE/0000182447 Pharmaceutical form(s) Solution for injection in pre-filled syringe Condition(s) / indication(s) Treatment of atopic dermatitis Route(s) of administration Subcutaneous use Contact for public enquiries Sanofi Winthrop Industrie Email: contact-us@sanofi.comTel: +31 202 453 703 Decision type PM: decision on the application for modification of an agreed PIP Decision date 06/12/2024 Compliance check done No Decision EMA/PE/0000182447 : EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for amlitelimabAdopted Reference Number: EMADOC-1700519818-1788084 English (EN) (233.08 KB - PDF)First published: 09/12/2025 View Share this page