EMEA-001577-PIP02-14-M05

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Key facts
Decision
Related information

Key facts

Invented name	Descovy
Active substance	emtricitabine tenofovir alafenamide
Therapeutic area	Infectious diseases
Decision number	P/0402/2022
PIP number	EMEA-001577-PIP02-14-M05
Pharmaceutical form(s)	Age-appropriate oral formulation Film-coated tablet
Condition(s) / indication(s)	Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration	Oral use
Contact for public enquiries	Gilead Sciences International Ltd E-mail: regulatory.pip@gilead.com Tel. +44 (0)1223 897300
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

List item

P/0402/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP02-14-M05) (PDF/302.56 KB) (new)

Adopted

First published: 19/09/2023
EMA/709116/2022

Related content

Related information

List item

Public summary of the evaluation of a proposed paediatric investigation plan: Emtricitabine / Propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin- 9-yl)propan-2-yl]-oxy}methyl)(phenoxy) phosphoryl]-Lalaninate, (2E)-but-2-ened... (PDF/87.54 KB)

First published: 10/03/2015
Last updated: 10/03/2015
EMA/793626/2014

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