EMEA-001501-PIP01-13-M07
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 |
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
|