EMEA-000236-PIP05-18
Key facts
Invented name |
Eylea
|
Active substance |
aflibercept
|
Therapeutic area |
Ophthalmology
|
Decision number |
P/0115/2019
|
PIP number |
EMEA-000236-PIP05-18
|
Pharmaceutical form(s) |
Solution for injection
|
Condition(s) / indication(s) |
Treatment of retinopathy of prematurity
|
Route(s) of administration |
Intravitreal use
|
Contact for public enquiries |
Bayer AG
Tel. +49 30300139003 |
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Compliance procedure number |
EMEA-C-000236-PIP05-18
|
Compliance opinion date |
15/10/2021
|
Compliance outcome |
positive
|