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
|