Is Nirmatrelvir + Ritonavir approved by the US FDA?

Drugs@FDA lists 1 application product line for Nirmatrelvir + Ritonavir, including PAXLOVID (COPACKAGED) (Prescription).

Is Nirmatrelvir + Ritonavir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nirmatrelvir + Ritonavir: Paxlovid.

Active substances

Nirmatrelvir + Ritonavir

US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PAXLOVID (COPACKAGED)	150MG;100MG; 300MG;100MG	tablet · oral	PFIZER	Prescription	25 May 2023

EMA European Union — centrally authorised medicines

Paxlovid Pfizer Europe MA EEIG · Authorised · authorised 28 Jan 2022 · ATC J05AE30

Therapeutic indication (EMA)

Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and paediatric patients 6 years of age and older weighing at least 20 kg who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19 (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PAXLOVID	02524031	100 MG; 150 MG	TABLET · ORAL	PFIZER CANADA ULC

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.