EMEA-003081-PIP01-21-M02 - paediatric investigation plan
(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
PIPHuman
Key facts
- Invented name
- Paxlovid
- 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/0503/2022
- PIP number
- EMEA-003081-PIP01-21-M02
- 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
- PM: decision on the application for modification of an agreed PIP
- Decision date