EMEA-001684-PIP01-14
Key facts
| Active substance |
Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
|
| Therapeutic area |
Ophthalmology
|
| Decision number |
P/0221/2015
|
| PIP number |
EMEA-001684-PIP01-14
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of genetic congenital retinal disorders
|
| Route(s) of administration |
Intraocular use
|
| Contact for public enquiries |
Novartis Europharm Limited
E-mail: paediatric.enquiries@novartis.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-001684-PIP01-14
|
| Compliance opinion date |
21/04/2017
|
| Compliance outcome |
positive
|