EMEA-002827-PIP01-20
Key facts
| Active substance |
Linear single strand of deoxyribonucleic acid (encoding human retinitis pigmentosa GTPase regulator [RPGR]) packaged in a recombinant adeno-associated virus protein capsid of serotype 5 (AAV5-hRKp.RPGR)
|
| Therapeutic area |
Ophthalmology
|
| Decision number |
P/0125/2021
|
| PIP number |
EMEA-002827-PIP01-20
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of Retinitis Pigmentosa
|
| Route(s) of administration |
Ophthalmic use
|
| Contact for public enquiries |
Janssen-Cilag International NV
E-mail: contact@janssen-emea.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|