EMEA-001501-PIP01-13-M07

Table of contents

Key facts

Invented name
Dupixent
Active substance
dupilumab
Therapeutic area
Dermatology
Decision number
P/0329/2021
PIP number
EMEA-001501-PIP01-13-M07
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of atopic dermatitis
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Regeneron Pharmaceuticals Inc

E-mail: clinicaltrials@regeneron.com
Tel. +914 8475385

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001501-PIP01-13-M07
Compliance opinion date
25/02/2022
Compliance outcome
positive

Decision

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