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
Applicant: Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Phone: +41 61 324 1111
 

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

Decision

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