Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Paxlovid 150 mg + 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
PF-07321332: Film-coated tablet (tablet). Pink, oval, with a dimension of approximately 17.6 mm in length and 8.6 mm in width debossed with ‘PFE’ on one side and ‘3CL’ on the other side. Ritonavir: Film-coated tablet (tablet). White to off white, capsule shaped tablets, with a dimension of approximately 17.1 mm in length and 9.1 mm in width, debossed with ‘H’ on one side and ‘R9’ on other side. |
Each pink film-coated tablet contains 150 mg of PF-07321332*.
Each white film-coated tablet contains 100 mg of ritonavir.
* PF-07321332 corresponds to the substance with the chemical 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.
Excipients with known effect: Each pink 150 mg film-coated tablet of PF-07321332 contains 176 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nirmatrelvir |
Nirmatrelvir (drug development code: PF-07321332), is a potent and selective peptidomimetic inhibitor of the SARS-CoV-2 3-chymotrypsin like protease, a virally encoded enzyme that is critical to the SARS-CoV-2 replication cycle. |
|
| Nirmatrelvir and Ritonavir |
Nirmatrelvir in combination with ritonavir 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. Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nsp5 protease. Inhibition of the SARS-CoV-2 Mpro leads to the prevention of viral replication. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, thereby providing increased plasma concentrations of nirmatrelvir. |
|
| Ritonavir |
Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism. |
| List of Excipients |
|---|
PF-07321332 film-coated tabletsTablet core: Microcrystalline cellulose Film coat: Hydroxypropyl methylcellulose (E464) Ritonavir film-coated tabletsTablet core: Copovidone Film coat: Hypromellose (E464) |
OPA/Al/PVC foil blister cards of 30 tablets.
Paxlovid is packaged in cartons containing 5 daily-dose blister cards of 30 tablets.
Each daily blister card contains 4 PF-07321332 tablets and 2 ritonavir tablets for morning and evening dose.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
EU/1/22/1625/001
Date of first authorisation: 28 January 2022
| Drug | Countries | |
|---|---|---|
| PAXLOVID | Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States |
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