EMEA-002827-PIP01-20

Table of contents

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
Tel: +32 14603876

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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