EMEA-002963-PIP01-21

Table of contents

Key facts

Active substance
Propan-2-yl (2S)-2-{[(S)-({(2R,3R,4R,5R)-5-[2-amino-6-(methylamino)-9H-purin-9-yl]-4-fluoro-3- hydroxy-4-methyloxolan-2-yl}methoxy)(phenoxy)phosphoryl]amino}propanoate; sulfuric acid (2:1) (AT-527 / RO7496998)
Therapeutic area
Infectious diseases
Decision number
P/0463/2021
PIP number
EMEA-002963-PIP01-21
Pharmaceutical form(s)
  • Age-appropriate oral dosage form
  • Tablet
Condition(s) / indication(s)
Treatment of Coronavirus disease 2019 (COVID-19)
Route(s) of administration
Oral use
Contact for public enquiries
Atea Pharmaceuticals, Inc.

Email: Dept-regulatory@ateapharma.com
Tel. +1 8572848891
 

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

Decision

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