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 
Switzerland
Tel. +41 613241111 
Fax +41 613248001
E-mail: paediatric.enquiries@novartis.com
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

Decision

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