Page contentsPage contents Key facts Decision Key facts Active substance denecimig Therapeutic area Blood and lymphatic system disorders Decision number EMA/PE/0000234140 PIP number EMA/PE/0000234140 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Treatment of Haemophilia A Route(s) of administration Subcutaneous use Contact for public enquiries Novo Nordisk A/S E-mail: paediatrics@novonordisk.com Tel.: +45 44448888 Decision type PM: decision on the application for modification of an agreed PIP Decision date 16/04/2025 Compliance check done No Decision EMA/PE/0000234140 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for denecimigAdopted Reference Number: EMADOC-1700519818-2037954 English (EN) (260.75 KB - PDF)First published: 30/06/2026 View Share this page