EMEA-001501-PIP09-21 - paediatric investigation plan
dupilumab
PIPHuman
Key facts
Invented name
Dupixent
Active Substance
dupilumab
Therapeutic area
Dermatology
Decision number
P/0120/2022
PIP number
EMEA-001501-PIP09-21
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of chronic inducible cold urticaria
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Sanofi-Aventis Groupe
contact-us@sanofi.com
+33 169745695
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0120/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP09-21)