EMEA-000527-PIP04-13-M01
Key facts
Invented name |
Lucentis
|
Active substance |
ranibizumab
|
Therapeutic area |
Ophthalmology
|
Decision number |
P/0010/2017
|
PIP number |
EMEA-000527-PIP04-13-M01
|
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 |
Novartis Europharm Limited
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000527-PIP04-13-M01
|
Compliance opinion date |
19/10/2018
|
Compliance outcome |
positive
|