Page contentsPage contents Key facts Decision Related content Key facts Active substance vatiquinone Therapeutic area Neurology Decision number P/0318/2021 PIP number EMEA-001238-PIP02-20 Pharmaceutical form(s) Oral solution Condition(s) / indication(s) Treatment of mitochondrial disease Route(s) of administration Oral use Contact for public enquiries PTC Therapeutics International Limited Tel. +353 19068700E-mail: medinfo@ptcbio.com Decision type P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Decision date 11/08/2021 Compliance check done No Decision P/0318/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan for vatiquinone (EMEA-001238-PIP02-20)Adopted Reference Number: EMA/427603/2021 English (EN) (217.62 KB - PDF)First published: 08/09/2022 View Related content Vatiquinone : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision English (EN) (93.4 KB - PDF)First published: 25/02/2026 View Share this page