EMEA-002961-PIP01-21-M01
Key facts
Invented name |
Regkirona
|
Active substance |
Regdanvimab
|
Therapeutic area |
Vaccines
|
Decision number |
P/0166/2022
|
PIP number |
EMEA-002961-PIP01-21-M01
|
Pharmaceutical form(s) |
Concentrate for solution for infusion
|
Condition(s) / indication(s) |
Treatment of Coronavirus disease 2019 (COVID-19)
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Celltrion Healthcare Hungary Kft.
Email: regulatory_eu@celltrion.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|