EMEA-003081-PIP01-21

Key facts

Active substance
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
Therapeutic area
Infectious diseases
Decision number
P/0566/2021
PIP number
EMEA-003081-PIP01-21
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Condition(s) / indication(s)
  • Prevention of Coronavirus disease 2019 (COVID-19)
  • Treatment of Coronavirus disease 2019 (COVID-19)
Route(s) of administration
Oral use
Contact for public enquiries
Pfizer Europe MA EEIG

Tel. +44 (0)1304 646 607
E-mail: pip_enquiries@pfizer.com

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

Decision

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