Paxlovid

RSS

(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 [PF-07321332] / ritonavir

Authorised
This medicine is authorised for use in the European Union.

Overview

Paxlovid is a medicine used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Paxlovid contains two active substances, PF-07321332 and ritonavir, in two different tablets.

This EPAR was last updated on 06/07/2022

Authorisation details

Product details
Name
Paxlovid
Agency product number
EMEA/H/C/005973
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 [PF-07321332]
  • ritonavir
International non-proprietary name (INN) or common name
  • (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 [PF-07321332]
  • ritonavir
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
Not yet assigned
Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
28/01/2022
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

01/07/2022 Paxlovid - EMEA/H/C/005973 - II/0009

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19 (see section 5.1).

Assessment history

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