EMEA-001553-PIP01-13-M02

Key facts

Active substance	Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)
Therapeutic area	Neonatology-Paediatric Intensive Care
Decision number	P/0367/2018
PIP number	EMEA-001553-PIP01-13-M02
Pharmaceutical form(s)	Nebuliser solution
Condition(s) / indication(s)	Treatment of lower respiratory tract disease caused by human respiratory syncytial virus (RSV)
Route(s) of administration	Inhalation use
Contact for public enquiries	Ablynx NV Tel. +32 92620000 E-mail: regulatory@ablynx.com
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0367/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171) (EMEA-001553-PIP01-13-M02) (PDF/141.25 KB)

Adopted

First published: 20/02/2019
EMA/796427/2018

Related information

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Public summary of the evaluation of the proposed paediatric investigation plan: Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171) for treatment of lower respiratory tract diseas... (PDF/83.69 KB)

First published: 25/11/2014
Last updated: 25/11/2014
EMA/691347/2014

Related documents

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Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/62.38 KB)

First published: 06/02/2023

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