EMEA-001624-PIP01-14-M05 - paediatric investigation plan
Nemolizumab
PIPHuman
Key facts
Active Substance
Nemolizumab
Therapeutic area
Dermatology
Decision number
P/0201/2022
PIP number
EMEA-001624-PIP01-14-M05
Pharmaceutical form(s)
Powder for solution for injection
Condition(s) / indication(s)
Treatment of atopic dermatitis
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Galderma International S.A.S.
E-mail: info@galderma.com
Tel. +41 584558592
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0201/2022 : EMA decision of 21 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M05)
Public summary of the evaluation of a proposed product-specific waiver: Humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A (CIM331)
Reference Number: EMA/422651/2015Summary:
Public summary of the evaluation of a proposed paediatric investigation plan.