EMEA-002886-PIP03-24 - paediatric investigation plan

Key facts

Active substance rocatinlimab Therapeutic area Respiratory, thoracic and mediastinal disorders Decision number EMEA-002886-PIP03-24 PIP number EMEA-002886-PIP03-24 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of asthma Route(s) of administration Subcutaneous use Contact for public enquiries Amgen Europe B.V Tel.: +44 (0)1223 420305 E-mail: [email protected] Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 03/01/2025 Compliance check done No

Decision

EMEA-002886-PIP03-24 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rocatinlimab Adopted Reference Number: EMA/581540/2024 English (EN) (190.52 KB - PDF) First published: 11/03/2026 View